Novotech is a leading global full-service contract research organization (CRO) that specializes in providing comprehensive clinical development solutions to the biotechnology and pharmaceutical industries.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 5.0 - 9.0 Lacs P.A.
Work from Office
Full Time
About the role The Project Finance Analyst is responsible for Support revenue recognition and unit recognition for each project with variance analysis on revenue and have accountability on revenue achieving forecast. Responsibility extends to working with project managers and senior project management team. Responsibilities: Support revenue recognition and unit recognition for each project with variance analysis on revenue and have accountability on revenue achieving forecast. Responsibility extends to working with project managers and senior project management team. Follow up with PMs for missing revenue and commentary for revenue analysis as needed. Support revenue management process in Financial Force (RM module). Assist with project finance reconciliation and profitability per project, reviewing of accrued and deferred revenue for reporting. Assisting with forecasting on project financials throughout the life of projects Support PM with all project finance activities. Minimum Qualifications Experience: Candidate must be a pro-active initiative-taker with a dynamic and resilient nature working in a fast- paced, challenging environment. Must have analytical critical thinking skills. Excellent interpersonal and relationship building skills. Solid Financial aptitude. Keen eye for process and quality improvement. Effective communication and organizational skills with business acumen. Prominent level of proficiency in using Microsoft Office and IT applications typical for administrative / business support roles. Financial Force experience desirable. Finance degree/diploma or equivalent. Minimum of 1-3 years experience in a similar position, preferably in CRO, Consultancy and/or Service business. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications Experience: Candidate must be a pro-active initiative-taker with a dynamic and resilient nature working in a fast- paced, challenging environment. Must have analytical critical thinking skills. Excellent interpersonal and relationship building skills. Solid Financial aptitude. Keen eye for process and quality improvement. Effective communication and organizational skills with business acumen. Prominent level of proficiency in using Microsoft Office and IT applications typical for administrative / business support roles. Financial Force experience desirable. Finance degree/diploma or equivalent. Minimum of 1-3 years experience in a similar position, preferably in CRO, Consultancy and/or Service business. Responsibilities: Support revenue recognition and unit recognition for each project with variance analysis on revenue and have accountability on revenue achieving forecast. Responsibility extends to working with project managers and senior project management team. Follow up with PMs for missing revenue and commentary for revenue analysis as needed. Support revenue management process in Financial Force (RM module). Assist with project finance reconciliation and profitability per project, reviewing of accrued and deferred revenue for reporting. Assisting with forecasting on project financials throughout the life of projects Support PM with all project finance activities.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 13.0 - 17.0 Lacs P.A.
Work from Office
Full Time
About the role: The Project Finance Business Partner are responsible for ensuring excellence in financial management and controls across assigned their assigned projects and portfolio. These are individual contributor roles working closely with Project Managers to manage project profitability, realization, client reporting and systems support/maintenance. Project Finance Business Partner will have additional responsibilities relating to Project Finance transformation having a key role in ensuring systems are updated and aligned with changing business practice, development and implementation of training materials and business processes as they relate to financial management in PSA to impacted departments across Novotech. It is anticipated that transformation responsibilities will be at least 50% of FTE, varying dependent on business need. Responsibilities: Ensure revenue recognition and forecasting support is provided throughout the lifecycle of all projects within assigned portfolios. Provide business partnering analysis on realization, profitability, budgets forecasts. Support Project Managers to identify and develop plans to resolve areas of poor financial performance. Ensure financial excellence targets are met on all assigned projects- realization, profitability, maintenance of deferred revenue balance where appropriate. Liaise with Project Management personnel offering timely advice, support and resolution to issues and omissions in month end financial process. Provide insight to senior management on project movements compared to forecast and contract. Manage the month end processes across the group, as they relate to revenue and forecast management, project performance. Oversee project finance close out activities and support final budget reconciliation by responsible PM to Client, Sites and Third-Party Vendors. Ensure compliance with any contracted project finance requirements for completed projects. Develop strong relationships with our customers, ensuring timely response to client queries and reporting requests. Oversee Project Finance responsibilities with respect to client contracting. E.g. milestone schedule development, payment terms, upfront fee negotiation. Ensure the timely and accurate set up of projects within the ERP and timely handover to Project Management. Initiate, lead and implement process improvement initiatives within the Project Finance group. Ensure Project Finance systems are updated and aligned with changing business practice; development and implementation of training materials and business processes as they relate to financial management in PSA, across impacted departments within Novotech organization. Minimum Qualifications Experience: Graduate in a finance, clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. At least five years experience within the pharmaceutical/CRO industry or related field for Project Finance Business Partner, and at least eight years experience within pharmaceutical/ CRO industry or related field for Senior Project Finance Business Partner. Strong financial acumen with a desire to drive business performance and accountability. Must have high level of proficiency in Microsoft office, specifically advanced Excel skills. Experience with Salesforce/Certinia ERP ecosystem. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Graduate in a finance, clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. At least five years experience within the pharmaceutical/CRO industry or related field for Project Finance Business Partner, and at least eight years experience within pharmaceutical/ CRO industry or related field for Senior Project Finance Business Partner. Strong financial acumen with a desire to drive business performance and accountability. Must have high level of proficiency in Microsoft office, specifically advanced Excel skills. Experience with SalesForce/Certinia ERP ecosystem. Responsibilities Ensure revenue recognition and forecasting support is provided throughout the lifecycle of all projects within assigned portfolios. Provide business partnering analysis on realization, profitability, budgets forecasts. Support Project Managers to identify and develop plans to resolve areas of poor financial performance. Ensure financial excellence targets are met on all assigned projects- realization, profitability, maintenance of deferred revenue balance where appropriate. Liaise with Project Management personnel offering timely advice, support and resolution to issues and omissions in month end financial process. Provide insight to senior management on project movements compared to forecast and contract. Manage the month end processes across the group, as they relate to revenue and forecast management, project performance. Oversee project finance close out activities and support final budget reconciliation by responsible PM to Client, Sites and Third-Party Vendors. Ensure compliance with any contracted project finance requirements for completed projects. Develop strong relationships with our customers, ensuring timely response to client queries and reporting requests. Oversee Project Finance responsibilities with respect to client contracting. E.g. milestone schedule development, payment terms, upfront fee negotiation. Ensure the timely and accurate set up of projects within the ERP and timely handover to Project Management. Initiate, lead and implement process improvement initiatives within the Project Finance group. Ensure Project Finance systems are updated and aligned with changing business practice; development and implementation of training materials and business processes as they relate to financial management in PSA, across impacted departments within Novotech organization.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 25.0 - 30.0 Lacs P.A.
Work from Office
Full Time
Brief Description: The core responsibility for this position is as a member of Novotech s Data Management group. The Senior Clinical Data Manager s (SCDM s) role is to control all aspects of data management and to ensure compliance with Good Clinical Data Management Practices (GCDMP). As an experienced CDM, the SCDM provides mentorship to junior staff and can also provide support to the project manager. Expectation of being a leader within the department by leading process improvements, new initiatives as well as training for junior colleagues. Minimum Qualifications & Experience: Graduate in a clinical or life sciences related field. At least eight to ten years experience in a similar role working in the research, pharmaceutical industry or a related field. Responsibilities: Member of the project team reporting to the Project Manager for integrated projects, the Senior Clinical Data Manager is responsible for planning, conducting, and managing all aspects of data management for a clinical trial according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements, and SOPs. Determination of project feasibility from a data management perspective. Understand the requirements of the project agreement and scope to ensure that Novotech performs these services as required. If full service, then collaborate with PM to ensure appropriate mitigation and contingencies are initiated. May function as Project Manager for stand-alone data management projects. Participates in project team meetings as required. Input into the preparation of RFPs in liaison with BD and the clinical team. Liaison with the project team and client for preparing and maintaining Data Management Plans. Responsible for all aspects of data management including: Design and review of database structure, validation rules and consistency checks. Operation of Clinical Data Management Systems. All data cleaning/validation tasks. Development of all key Data Management Documents. Liaison with client companies / monitoring staff as appropriate, ensuring effective study communication with internal and external stakeholders. Liaison with external service providers on Data Management projects as appropriate. Assist in the development of protocols as required. Supervision and training support for junior and contract Data Management staff as required. Adherence to company Quality Policy and procedures applicable to fulfilling job responsibilities. Active contribution in Data Management process improvement including identification of and participation in process improvement initiatives. Perform accurate study financial projections and maintain monthly project financials. Ensure changes in scope are identified and actioned accordingly. Provide expert assistance and input into internal cross-functional projects including clinical research and regulatory affairs, as assigned. Project management of internal IT-based company projects as assigned (e.g., intranet development, client database applications etc.). Active contribution to company business development initiatives, including involvement in the implementation of data management plans for business development in the company in general. Participation in industry fora (conferences, professional association committee work, etc.) as a means of professional development as well as promotion of Novotech s image in industry.
Bengaluru
INR 16.0 - 18.0 Lacs P.A.
Work from Office
Full Time
The core responsibility for this position is as a member of Novotech s Data Management group. The Senior Clinical Data Manager s (SCDM s) role is to control all aspects of data management and to ensure compliance with Good Clinical Data Management Practices (GCDMP). As an experienced CDM, the SCDM provides mentorship to junior staff and can also provide support to the project manager. Expectation of being a leader within the department by leading process improvements, new initiatives as we'll as training for junior colleagues. Minimum Qualifications Experience: Graduate in a clinical or life sciences related field. At least eight to ten years experience in a similar role working in the research, pharmaceutical industry or a related field. Responsibilities: Member of the project team reporting to the Project Manager for integrated projects, the Senior Clinical Data Manager is responsible for planning, conducting, and managing all aspects of data management for a clinical trial according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements, and SOPs. Determination of project feasibility from a data management perspective. Understand the requirements of the project agreement and scope to ensure that Novotech performs these services as required. If full service, then collaborate with PM to ensure appropriate mitigation and contingencies are initiated. May function as Project Manager for stand-alone data management projects. Participates in project team meetings as required. Input into the preparation of RFPs in liaison with BD and the clinical team. Liaison with the project team and client for preparing and maintaining Data Management Plans. Responsible for all aspects of data management including: Design and review of database structure, validation rules and consistency checks. Operation of Clinical Data Management Systems. All data cleaning/validation tasks. Development of all key Data Management Documents. Liaison with client companies / monitoring staff as appropriate, ensuring effective study communication with internal and external stakeholders. Liaison with external service providers on Data Management projects as appropriate. Assist in the development of protocols as required. Supervision and training support for junior and contract Data Management staff as required. Adherence to company Quality Policy and procedures applicable to fulfilling job responsibilities. Active contribution in Data Management process improvement including identification of and participation in process improvement initiatives. Perform accurate study financial projections and maintain monthly project financials. Ensure changes in scope are identified and actioned accordingly. Provide expert assistance and input into internal cross-functional projects including clinical research and regulatory affairs, as assigned. Project management of internal IT-based company projects as assigned (eg, intranet development, client database applications etc). Active contribution to company business development initiatives, including involvement in the implementation of data management plans for business development in the company in general. Participation in industry fora (conferences, professional association committee work, etc) as a means of professional development as we'll as promotion of Novotech s image in industry
Bengaluru, Karnataka, India
Not disclosed
On-site
Full Time
About the role The Project Finance Analyst is responsible for ensuring excellence in financial management and controls across assigned their assigned projects and portfolio. These are individual contributor roles working closely with Project Managers to manage project profitability, realization, client reporting and systems support/maintenance. Responsibilities: Ensure revenue recognition and forecasting support is provided throughout the lifecycle of all projects within assigned portfolios. Provide business partnering analysis on realization, profitability, budgets & forecasts on assigned projects. Support Project Managers to identify and develop plans to resolve areas of poor financial performance. Ensure financial excellence targets are met on all assigned projects- realization, profitability, maintenance of deferred revenue balance where appropriate. Liaise with Project Management personnel offering timely advice, support and resolution to issues and omissions in month end financial process. Provide insight to senior management on project movements compared to forecast and contract on assigned projects. Manage the month end processes on assigned projects as they relate to revenue and forecast management, and project performance. Oversee project finance close out activities; complete final budget reconciliation in collaboration with PM and other stakeholders, including client, sites and third party vendors. Ensure compliance with any contracted project finance requirements for completed projects. Develop strong relationships with our customers, ensuring timely response to client queries and reporting requests. Oversee Project Finance responsibilities with respect to client contracting. E.g. milestone schedule development, payment terms, upfront fee negotiation. Ensure the timely and accurate set up of projects within the ERP and timely handover to Project Management. Contribute to process improvement initiatives within the Project Finance group. Minimum Qualifications & Experience: Graduate in a finance, clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. At least two years' experience within the pharmaceutical/CRO industry or related field. Strong financial acumen with a desire to drive business performance and accountability. Must have high level of proficiency in Microsoft office, specifically advanced Excel skills. Experience with SalesForce/Certinia ERP ecosystem. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Show more Show less
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 13.0 - 17.0 Lacs P.A.
Work from Office
Full Time
About the role: The Proposal, Budget and Contracts Manager is responsible for the development and preparation of proposals, budgets, and contracts for new business. The PBC Manager will be accountable for generating high quality and timely proposals, budgets, and contracts by working closely with the Business Development team and Projects Managers. PBC Managers are expected to have an excellent understanding of the development of new opportunity documents. PBC Managers are capable of document development for global program management, full-service, multi-CRO and more complex projects. PBC Managers may be required to mentor junior staff and are expected to contribute to departmental activities and process initiatives. Minimum Qualifications & Experience: Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. At least five years experience within the pharmaceutical industry as a PBC specialist or equivalent. At least three years experience preparing budgets, contracts and proposals or demonstrated exceptional capabilities in proposal, contract, and budget development within Novotech. Previous experience working directly with clients. Must be able to communicate clearly, able to prioritise and meet deadlines. Responsibilities: Develop proposal: Prepare high quality proposals and presentation materials. Collate required content and finalize proposal (involves substantive editing & drafting to ensure readability, consistency in formatting to ensure that proposals accurately reflect customers requirements and is consistent with Novotech branding guidelines). Ensure proposal templates remain relevant and compliant and of a high visual standard. Research, compile and present statistics and company information. Consult with internal team from other departments within Novotech to obtain information required to respond to RFP questions. Develop budget: Prepare budget for projects based on client information provided to schedule timeframe. Prepare other budgets elements (client mapping etc.) as required to timeframes. Consult with vendors to obtain quotations. Develop Contracts: Prepare all new client contracts and execute in accordance with agreed timeframes and guidance. Obtain appropriate format of Budget for inclusion in contracts. Contracts executed in accordance with Novotech Contract Review SOP. Follow Start Up Work Authorization process to activate project for handover to Operations team. Contact vendors and obtain quotes. Contact vendors for quotes based on protocol and vendor lists. Engage Operation team as required for assistance. Process Improvement: Assist in the review and development of processes and documentation as required. Developing Others: Train and mentor PBC Associate and PBC Specialists in development of proposals, budgets, and contracts. Provide a positive role model and provide feedback on progress in a constructive manner. Be able to identify knowledge deficiencies in junior star and provide training or make recommendation for training. Other: Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communication with external parties is presented in a positive and professional manner. Attend calls with internal teams and clients in development of opportunity documents Maintain and update opportunity status within SalesForce. Maintain contracts records in SalesForce and SharePoint. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. At least five years experience within the pharmaceutical industry as a PBC specialist/manager or equivalent. At least three years experience preparing budgets, contracts and proposals or demonstrated exceptional capabilities in proposal, contract and budget development within Novotech. Advanced Microsoft Excel skills, including macros development. Previous experience working directly with clients. Must be able to communicate clearly, able to prioritise and meet deadlines. Must have advanced Microsoft Office capabilities, specifically Excel, Word and PowerPoint. Responsibilities Develop Proposal Prepare high quality proposals and presentation materials. Collate required content and finalise proposal (involves substantive editing & drafting to ensure readability, consistency in formatting to ensure that proposals accurately reflect customers requirements and is consistent with Novotech branding guidelines). Ensure proposal templates remain relevant and compliant and of a high visual standard. Research, compile and present statistics and company information. Liaise with internal team from other departments within Novotech to obtain information required to respond to RFP questions. Develop Budget Prepare budget for projects based on client information provided to schedule timeframe. Prepare other budgets elements (client mapping etc.) as required to timeframes. Liaise with vendors to obtain quotations. Develop Contracts Prepare all new client contracts and execute in accordance with agreed timeframes and guidance. Obtain appropriate format of Budget for inclusion in contracts. Contracts executed in accordance with Novotech Contract Review SOP. Follow Start Up Work Authorisation process to activate project for handover to Operations team. Contact vendors and obtain quotes. Contact vendors for quotes based on protocol and vendor lists. Engage Operation team as required for assistance. Process Improvement/ PBC Transformation Activities Identify and implement process improvements and initiatives to enhance efficiency and streamline activities across PBC team. Implement revisions to the Novotech pricing tool as required per business needs. Work cross-functionally with other departments in Novotech to develop and implement processes and systems to improve efficiency, transparency and quality. Develop and implement training of PBC and wider Novotech staff as required following successful delivery of Initiative. Developing Others Train and mentor PBC Associates and PBC Specialists in development of proposals, budgets and contracts. Provide a positive role model and provide feedback on progress in a constructive manner. Be able to identify knowledge deficiencies in junior staff and provide training or make recommendation for training. Other Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communication with external parties is presented in a positive and professional manner. Attend calls with internal teams and clients in development of opportunity documents. Maintain and update opportunity status within Salesforce. Maintain contracts records in Salesforce and SharePoint.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 8.0 - 11.0 Lacs P.A.
Work from Office
Full Time
About the role: The Senior Regulatory Start Up Associate is primarily responsible for planning, preparation, review of country and site level ethics and regulatory authority applications and submissions during project start-up, in compliance with ICH-GCP and local regulatory requirements, to ensure timely clinical trial approval. Minimum Qualifications Experience: Graduate in a clinical, pharmacy or life sciences related field. At least 3-5 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment. Responsibilities: Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries. Work within the scope of the Regulatory Start-Up plan or other applicable project plan, relevant SOPs, and ICH-GCP. Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate. Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals. May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities. Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Ensure submission packages are accurate and complete per local requirements. Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe. Follow submission, application to approval. May serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities. Prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements. Escalate any issue to the RSM and/or PM and provides rationale for submission/approval delays, and contingency plan to mitigate impact. Perform country and site Informed Consent Form (ICF) customization in line with local requirements. Initiate translation of submission documents as applicable and review translated documents before submission. Review and approve proposed packaging and labelling for clinical trial material. Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required. Register project onto an official clinical trial registry as agreed to with Client and update status as required. Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents. Serve as an independent essential document reviewer and performs 2nd review of Activation Forms for IP release if required. Where applicable, may act as a Country Lead for projects with no RSM. At least 3-5 years Regulatory Start-up experiences in clinical industry. Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Participate in company start-up initiatives, contributing to development and maintenance of regulatory start-up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements. Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs. Serve as the local subject matter expert on specialized aspects of regulatory and start -up activities. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications Experience: Graduate in a clinical, pharmacy or life sciences related field. At least 3-5 years of related experience in either a CRO, pharmaceutical or clinical/hospital environment. Responsibilities: Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries. Work within the scope of the Regulatory Start-Up plan or other applicable project plan, relevant SOPs, and ICH-GCP. Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate. Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals. May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities. Prepare and submits Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Ensure submission packages are accurate and complete per local requirements. Review and follow-up on comments/questions raised by reviewing bodies and advise/contribute to response. Submit response with Client approval within timeframe. Follow submission, application to approval. May serve as a point of contact for Regulatory Authorities, Ethics Committees/Review Boards and other local authorities. Prepare and submit ongoing amendments, notifications, safety reports and study related materials required by Regulatory Authorities, Ethics Committees/Review Boards and other local authorities as per local requirements. Escalate any issue to the RSM and/or PM and provides rationale for submission/approval delays, and contingency plan to mitigate impact. Perform country and site Informed Consent Form (ICF) customisation in line with local requirements. Initiate translation of submission documents as applicable and review translated documents before submission. Review and approve proposed packaging and labelling for clinical trial material. Prepare and submits import/export license applications and management of licenses and custom clearance thereafter if required. Register project onto an official clinical trial registry as agreed to with Client and update status as required. Submit regulatory and ethics documents and relevant study correspondence to the trial master file and ensures accuracy and completeness of these documents. Serve as an independent essential document reviewer and performs 2nd review of Activation Forms for IP release if required. Where applicable, may act as a Country Lead for projects with no RSM. At least 3-5 years Regulatory Start-up experiences in clinical industry. Responsible for development of master and country ICFs, study specific forms and other documents required for Central EC/IRB applications, local EC/Governance applications, Regulatory Authority applications, and other local regulatory authorities or site submissions as required. Participate in company start-up initiatives, contributing to development and maintenance of regulatory start-up processes, tools and SOPs. Identify areas of inefficiency in process and make recommendations for improvements. Assist with RSA training in the development and delivery of training in conjunction with Learning and Development Manager and serve as a mentor to junior RSAs. Serve as the local subject matter expert on specialised aspects of regulatory and start -up activities.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 7.0 - 11.0 Lacs P.A.
Work from Office
Full Time
About the role: The Senior Finance Specialist is responsible for managing employee expense claims, ensuring compliance with company policies, and administering the corporate card program. This role requires attention to detail, a strong understanding of financial controls, and excellent customer service skills to support employees with their claims and card-related queries. Minimum Qualifications & Experience: Bachelor s degree in accounting, Finance, Business Administration, or a related field. 6+ years of experience in expense claims processing, accounts payable, or corporate card administration. Proficiency in Concur and Certinia system, MS Excel, and financial reporting tools. Strong attention to detail, problem-solving abilities, and excellent communication skills. Familiarity with corporate expense policies, tax implications, and financial compliance. Experience working in a shared services or multinational environment. Prior experience with corporate card programs and expense management tools. Ability to handle confidential information with integrity and discretion. Responsibilities: Expense Claims Processing: Review and process employee expense claims in accordance with company policies and guidelines. Ensure receipts and supporting documents comply with company policies and requirements. Verify approvals and escalate non-compliant claims to management. Coordinate with employees to resolve discrepancies or missing documentation. Process reimbursements through the Certinia system and liaise with Accounts Payable for timely payments. Assist in monthly expense accruals and reporting. Support Concur Technical team lead for new entity roll out and system enhancement initiatives. Stay updated on new Concur enhancements, features, and industry best practices, and proactively implement improvements to the system Manage helpdesk tickets, resolve user issues, and escalate problems as needed to ensure timely resolution. Corporate Card Administration: Manage the issuance, renewal, and cancellation of corporate credit cards. Maintain corporate cardholder records and ensure adherence to company policies. Monitor transactions for policy violations and follow up with employees as needed. Reconcile corporate card statements and ensure timely settlements. Support employees with card-related inquiries, including lost/stolen card replacements. Collaborate with the bank or card provider for troubleshooting and program enhancements. Compliance & Reporting: Ensure compliance with company policies, tax regulations, and audit requirements. Generate and analyse expense reports to identify trends, policy violations, and cost-saving opportunities. Assist in audits by providing required documentation and explanations. Recommend process improvements to enhance efficiency and reduce errors. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: Bachelor s degree in accounting, Finance, Business Administration, or a related field. 6+ years of experience in expense claims processing, accounts payable, or corporate card administration. Proficiency in Concur and Certinia system, MS Excel, and financial reporting tools. Strong attention to detail, problem-solving abilities, and excellent communication skills. Familiarity with corporate expense policies, tax implications, and financial compliance. Experience working in a shared services or multinational environment. Prior experience with corporate card programs and expense management tools. Ability to handle confidential information with integrity and discretion. Expense Claims Processing: Review and process employee expense claims in accordance with company policies and guidelines. Ensure receipts and supporting documents comply with company policies and requirements. Verify approvals and escalate non-compliant claims to management. Coordinate with employees to resolve discrepancies or missing documentation. Process reimbursements through the Certinia system and liaise with Accounts Payable for timely payments. Assist in monthly expense accruals and reporting. Support Concur Technical team lead for new entity roll out and system enhancement initiatives. Stay updated on new Concur enhancements, features, and industry best practices, and proactively implement improvements to the system Manage helpdesk tickets, resolve user issues, and escalate problems as needed to ensure timely resolution. Corporate Card Administration: Manage the issuance, renewal, and cancellation of corporate credit cards. Maintain corporate cardholder records and ensure adherence to company policies. Monitor transactions for policy violations and follow up with employees as needed. Reconcile corporate card statements and ensure timely settlements. Support employees with card-related inquiries, including lost/stolen card replacements. Collaborate with the bank or card provider for troubleshooting and program enhancements. Compliance & Reporting: Ensure compliance with company policies, tax regulations, and audit requirements. Generate and analyse expense reports to identify trends, policy violations, and cost-saving opportunities. Assist in audits by providing required documentation and explanations. Recommend process improvements to enhance efficiency and reduce errors.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 20.0 - 25.0 Lacs P.A.
Work from Office
Full Time
About the role: The Senior Accounts Receivable Specialist is primarily responsible for all internal and external customers of Novotech and coordinating with associates with the AR team. Provides financial support by ensuring the company receives payments for services and managing the process of recording the transactions by posting receipts and resolving discrepancies according to established policies and procedures in an efficient, timely and accurate manner. Regular follow up with customers to ensure all invoices processed and paid in timely manner. Responsibilities: Help with the process of preparing, verifying, and processing invoices for services rendered. Collaborate the process of collections on accounts by sending invoice reminders and communication with customers via phone, email, fax, or mail. Work with team involved in customer payments, recording cash, checks, and Wire transactions, and entering them into the general ledger or accounting software. Resolve collections by examining customer payment plans, payment history, credit line. Generate monthly, quarterly, or annual financial statements and reports detailing paid and unpaid invoices and other accounts receivable activity. Protect organization s value by keeping information confidential. Collection management, including reviewing credit memos or revised invoices. Participate in process improvements and efficiency into the AR function, ensuring common processes are applied to all agencies and leading practices are adopted through staff training and system enhancements. Minimum Qualifications & Experience: Strong hold on Excel and Power Point (MS). Candidate must be a pro-active self-starter with a dynamic and resilient nature working in a fast- paced, challenging environment. Must have analytical, problem solving. Excellent interpersonal and relationship building skills. Extremely well organized and detailed oriented with demonstrated follow-up skills. Strong Financial aptitude. Proficient in PC applications to include MS Word, Excel, and PowerPoint. Experience in Net Suite will be added advantage. 6-8 years of relevant experience in a professional work environment with a minimum of 4 years experience in Accounts Receivable. Keen eye for process and quality improvement. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: Strong hold on excel and Power Point (MS). Candidate must be a pro-active self-starter with a dynamic and resilient nature working in a fast- paced, challenging environment. Must have analytical, problem solving. Excellent interpersonal and relationship building skills. Extremely well organized and detailed oriented with demonstrated follow-up skills. Strong Financial aptitude. Proficient in PC applications to include MS Word, Excel, and PowerPoint. Experience in Net Suite will be added advantage. 6-8 years of relevant experience in a professional work environment with a minimum of 4 years experience in Accounts Receivable. Keen eye for process and quality improvement. Responsibilities: Help with the process of preparing, verifying, and processing invoices for services rendered. Collaborate the process of collections on accounts by sending invoice reminders and communication with customers via phone, email, fax, or mail. Work with team involved in customer payments, recording cash, checks, and Wire transactions, and entering them into the general ledger or accounting software. Resolve collections by examining customer payment plans, payment history, credit line. Generate monthly, quarterly, or annual financial statements and reports detailing paid and unpaid invoices and other accounts receivable activity. Protect organization s value by keeping information confidential. Collection management, including reviewing credit memos or revised invoices. Participate in process improvements and efficiency into the AR function, ensuring common processes are applied to all agencies and leading practices are adopted through staff training and system enhancements.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 1.0 - 5.0 Lacs P.A.
Work from Office
Full Time
Brief Position Description: The Investigator Grant Specialist is responsible for the development of Investigator grant, supporting the various groups related to use of industry systems such as Grant Plan. The Investigator Grant Specialist will work closely with Project Management and Clinical Operations to ensure timely delivery of site budget templates. The ideal candidate will be professional, analytical and possess excellent written and verbal communication skills. Minimum Qualifications & Experience: Bachelor s Degree in a relevant field (science or other) or professional certification. Experience in Clinical Trial industry. Knowledge regarding industry standard benchmarks, fair market value and proven expertise using investigator grant software (e.g. GrantPlan). Experience in reviewing and understanding study protocols, study budgets, as well as other technical, medical and legal documents related to investigator grants. Excellent communication and organisational skills. Business acumen. Attention to detail. Strong planning and problem-solving skills. Computer expertise with document and spreadsheet applications. Responsibilities: Responsible for the development of investigator grant using industry standard systems. Review study protocols work closely with Project Managers to ensure accurate, complete and timely deliveries of Investigator Grants. Provide initial budget estimates as requested by clients Apply Industry standard of care concepts into building budget model. Address questions related to Fair Market Value. Communicate with vendor for system related issues. Manage list of user access to required systems. Track finalised budgets and ensure reporting as required. Provide training to groups as appropriate. Work proactively to implement process improvement that reduces cycle time. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: At least 12-36 months of experience in a clinical research organization or equivalent. Minimum Batchelor s degree in Life science or related field Experience working in Investigator Payment Process. Experience working in CTMS/Veeva. Experience working in Grant Plan. Understanding of Subject Visit Tracking in CTMS. Strong hold on excels and Power Point (MS). Effective communication skills. Must have analytical, problem solving, Excellent verbal and written communication and negotiation skills. Excellent interpersonal and relationship building skills. Extremely well organized and detailed oriented with demonstrated follow-up skills. Should have prior background in the pharmaceutical, CRO or healthcare industry. Responsibilities: Investigator Payment Activity To review, update and track all payments in CTMS appropriately. To route correspondence appropriately and ensure all queries raised have been assigned to the correct team member in a timely manner. To escalate payment issues/delays appropriately. To review payments in line with visit data in CTMS to ensure sites are being paid timely accurate and efficient manner and escalate delays/ issues appropriately. Communicate effectively with Project Managers, regarding payment enquiries and managing their expectations accordingly. To support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract. Assists with maintaining schedule for patient visit payments per contract with the Sponsor and the Site. Process all site payments for patient visits. Review the site payment report based on the required due date for payments to be made to make sure the report is correct and free of errors before processing any payments. Prepare Investigator Payment report for study status meetings as requested by Project Manager. Be accountable for the quality of how each study assigned is set-up and maintained, ensuring payments are correct and that all work conducted is in accordance with Investigator Payment processes and procedures and is audit Analyse and assess SVT setup requirement based onstudy type (simple/complex/cohort). Create site SVTs based on CTRAs received from CRAs. Setup Master/Site specific SVT templates in CTMS within the required timelines and ensure accurate templates are built in before release to study teams. Be aware of and adhere to company processes in areas relevant to Investigator Grant Specialist. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when conducting IGS role. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Investigator Grants Activity Responsible for the development of investigator grant using industry standard systems. Review study protocols work closely with Project Managers to ensure accurate, complete, and timely deliveries of Investigator Grants. Candidate will be assigned in the complex projects. Provide initial budget estimates as requested by clients. Apply Industry standard of care concepts into building budget model. Address questions related to Fair Market Value. Communicate with vendor for system related issues. Manage list of user access to required systems. Track finalized budgets and ensured reporting as required.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 4.0 - 8.0 Lacs P.A.
Work from Office
Full Time
Brief Position Description: We are seeking for a highly skilled and experienced Senior System Engineer to join our team. The ideal candidate will be responsible for managing and resolving Level 2 and 3 support tickets, and managing as part of a larger global team: Microsoft Office 365, Azure and on-premise Active Directory environments. This role requires a proactive and solution-oriented individual with excellent technical and communication skills. Minimum Qualifications & Experience: Bachelor s degree in Computer Science, Information Technology, or a related field (or equivalent experience); Relevant certifications such as Microsoft Certified: Azure Administrator, Microsoft 365 Certified: Enterprise Administrator, or similar. Proven experience with Level 2 IT support, including troubleshooting hardware, software, and network issues. Proficiency in Microsoft 365 administration and deployments, including: Entra, Intune, Exchange Online, Teams, and SharePoint. Strong knowledge of Azure infrastructure and services, such as VMs, Azure AD, and Resource Groups. Understanding of Active Directory Hybrid sync to Microsoft 365 services. Hands-on experience in data centre management, including server hardware and virtualization technologies (e.g., VMware, Hyper-V). Understanding of network components including: firewalls, VPNs and routing. Solid understanding of network security components including: firewalls, VPNs, and reverse proxy products. Responsibilities: Support and Troubleshooting: Handle and resolve Level 2 and 3 technical support tickets, and project tasks ensuring timely issue resolution. Collaborate with Level 1 and Level 3 teams for complex escalations and root cause analysis. Provide guidance and mentorship to junior support staff. Microsoft Office 365 and Azure Administration: Manage, configure, and troubleshoot Office 365 applications, including Exchange, Teams, SharePoint, and OneDrive. Administer and optimize Azure resources, including virtual machines, storage, and networking. Management and troubleshooting of Microsoft Intune configuration policies and application deployment for Windows OS. Ensure compliance with security policies and implement best practices in the Office 365 and Azure environments. Data Center Management: Manage data centre operations, including servers, storage, and networking equipment. In conjunction with a global technology team Monitor and maintain the health, performance, and security of data centre infrastructure. Perform routine backups and patch management. Coordinate hardware installations, upgrades, and maintenance activities. Monitor, maintain and manage a global layer 2 and layer 3 network with heterogenous vendor equipment as part of a large support team across multiple locations. Understanding of VLANs, Routing and Multi site networking topologies. Familiarity with PKI authentication and Wireless Network authentication. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Brief Position Description: We are seeking for a highly skilled and experienced Senior System Engineer to join our team. The ideal candidate will be responsible for managing and resolving Level 2 and 3 support tickets, and managing as part of a larger global team: Microsoft Office 365, Azure and on-premise Active Directory environments. This role requires a proactive and solution-oriented individual with excellent technical and communication skills. Minimum Qualifications & Experience: Bachelor s degree in Computer Science, Information Technology, or a related field (or equivalent experience); Relevant certifications such as Microsoft Certified: Azure Administrator, Microsoft 365 Certified: Enterprise Administrator, or similar. Proven experience with Level 2 IT support, including troubleshooting hardware, software, and network issues. Proficiency in Microsoft 365 administration and deployments, including: Entra, Intune, Exchange Online, Teams, and SharePoint. Strong knowledge of Azure infrastructure and services, such as VMs, Azure AD, and Resource Groups. Understanding of Active Directory Hybrid sync to Microsoft 365 services. Hands-on experience in data centre management, including server hardware and virtualization technologies (e.g., VMware, Hyper-V). Understanding of network components including: firewalls, VPNs and routing. Solid understanding of network security components including: firewalls, VPNs, and reverse proxy products. Responsibilities: Support and Troubleshooting: Handle and resolve Level 2 and 3 technical support tickets, and project tasks ensuring timely issue resolution. Collaborate with Level 1 and Level 3 teams for complex escalations and root cause analysis. Provide guidance and mentorship to junior support staff. Microsoft Office 365 and Azure Administration: Manage, configure, and troubleshoot Office 365 applications, including Exchange, Teams, SharePoint, and OneDrive. Administer and optimize Azure resources, including virtual machines, storage, and networking. Management and troubleshooting of Microsoft Intune configuration policies and application deployment for Windows OS. Ensure compliance with security policies and implement best practices in the Office 365 and Azure environments. Data Center Management: Manage data centre operations, including servers, storage, and networking equipment. In conjunction with a global technology team Monitor and maintain the health, performance, and security of data centre infrastructure. Perform routine backups and patch management. Coordinate hardware installations, upgrades, and maintenance activities. Monitor, maintain and manage a global layer 2 and layer 3 network with heterogenous vendor equipment as part of a large support team across multiple locations. Understanding of VLANs, Routing and Multi site networking topologies. Familiarity with PKI authentication and Wireless Network authentication. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 6.0 - 9.0 Lacs P.A.
Work from Office
Full Time
Brief Position Description: The core responsibility for this position is as a member of the Data Management department at Novotech. The (Senior) Clinical Data Programmer will be responsible for programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP). Minimum Qualifications & Experience: Graduate in information science or life science related field, or similar. Two years experience in a similar role in a CRO or pharmaceutical company. Preferably with hand-on experience with Custom Functions/C# and Veeva EDC. Responsibilities: The Clinical Data Programmer shall be responsible for programming activities on a project. This shall include designing and implementation of clinical database, programming of data review listings and programming of data reconciliation. The CDP shall ensure quality standards per SOPs and ICH-GCP. The CDP shall be responsible for designing, programming, testing and maintenance of clinical trial databases in different clinical trial applications in accordance with Novotech standards. Perform external data loads, i.e. labs, ECGs etc., as needed. Act as liaison with vendors to establish data transfer specifications standards. Ensure all programming activities and processes performed are conducted in accordance with standard operating procedures and good programming practices. Experience in developing, validating and maintaining clinical trials built in different EDC applications. Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Brief Position Description: The core responsibility for this position is as a member of the Data Management department at Novotech. The (Senior) Clinical Data Programmer will be responsible for programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP). Minimum Qualifications & Experience: Graduate in information science or life science related field, or similar. Two years experience in a similar role in a CRO or pharmaceutical company. Preferably with hand-on experience with Custom Functions/C# and Veeva EDC. Responsibilities: The Clinical Data Programmer shall be responsible for programming activities on a project. This shall include designing and implementation of clinical database, programming of data review listings and programming of data reconciliation. The CDP shall ensure quality standards per SOPs and ICH-GCP. The CDP shall be responsible for designing, programming, testing and maintenance of clinical trial databases in different clinical trial applications in accordance with Novotech standards. Perform external data loads, i.e. labs, ECGs etc., as needed. Act as liaison with vendors to establish data transfer specifications standards. Ensure all programming activities and processes performed are conducted in accordance with standard operating procedures and good programming practices. Experience in developing, validating and maintaining clinical trials built in different EDC applications. Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 9.0 - 12.0 Lacs P.A.
Work from Office
Full Time
About the role: The IT Service Desk Analyst works within the IT department and is responsible for ensuring that efficient and effective responses to requests for day-to-day technical advice and support to internal employees and systems. The role will need to display a high level of competency in customer service, technical troubleshooting, and record keeping, to ensure customers receive the help required, and downstream teams receive the data they require. The IT Service Desk Analyst performs both virtual support for all global Novotech staff, and Office/Desktop support for the office they work from. The IT Analyst is expected to pro-actively look for ways to improve IT Service Delivery, whether through new processes or new technology, and work to implement those improvements in the company. There may be requirements to assist with IT Projects being run by other teams or senior team members. Minimum Qualifications & Experience: Strong customer service skills. Strong verbal and written communication skills. Strong skills in MS Office, Active Directory/Azure, Windows OS, Exchange user management. ITIL V4 Foundations. MSDST, CCNP, or MCDST certification desirable. Responsibilities: The responsibilities will vary day to day and may include: Works within the IT service desk team to provide speedy and efficient resolution of Service Desk tickets/calls via Service Desk ticket review and Service Desk system stats in line with SLAs. Help develop processes to reduce time taken to resolve Service Desk issues. Identify knowledge base gaps through daily ticket review. Create and update Novotech Service Desk SOP s/Knowledge Base. Adhere to all published Policies, SOP s, DOP s, WIs, and Knowledge Base Articles. Highlight & escalate any conflicts between these documents to your line manager and document in related tickets. Actively participate in continual service improvement programs (i.e. knowledge discovery & documentation, process improvement, technology discovery & implementation etc). Escalate to the appropriate team where necessary with detailed notes on investigation of the issue. Find opportunities for service improvement and engage the relevant teams to reduce Service Desk time taken to resolve/escalate Incidents & Requests. Assist all other Service Desk team members in following Novotech Service Desk SOP s and highlight to line management where additional training or clarifications are required. Fluent written and verbal English. Service Desk Operation Installation of hardware and software based on the documented processes within the knowledge base. In office-based locations, attend the sites either according to a schedule or ad-hoc arrangement, as directed by the team lead, with an expectation of 3 days in the office under a hybrid model. Manage local stock rooms, including reporting on current stock volumes and ordering of new stock to meet anticipated demand. Respond to incoming events in a timely manner in line with KPIs and SLAs. Update and resolve events received by the Service Desk team in a timely manner in line with KPIs and SLAs. Using the Novotech Service Desk Ticket system to record all data regarding day-to-day tasks. Self-logging of tasks completed outside of the scope of the ticket is required. E.g. walk-up, IM or telephone. Maintain accurate records and documentation of all interactions and resolutions within the Service Desk ticketing system, ensuring compliance with data protection and confidentiality guidelines. Provide training documentation and training sessions to non-IT staff on use of IT Systems and general Novotech setup. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: Strong customer service skills. Strong verbal and written communication skills. Strong skills in MS Office, Active Directory/Azure, Windows OS, Exchange user management. ITIL V4 Foundations. MSDST, CCNP, or MCDST certification desirable. Responsibilities: The responsibilities will vary day to day and may include: Works within the IT service desk team to provide speedy and efficient resolution of Service Desk tickets/calls via Service Desk ticket review and Service Desk system stats in line with SLAs. Help develop processes to reduce time taken to resolve Service Desk issues. Identify knowledge base gaps through daily ticket review. Create and update Novotech Service Desk SOP s/Knowledge Base. Adhere to all published Policies, SOP s, DOP s, WIs, and Knowledge Base Articles. Highlight & escalate any conflicts between these documents to your line manager and document in related tickets. Actively participate in continual service improvement programs (i.e. knowledge discovery & documentation, process improvement, technology discovery & implementation etc). Escalate to the appropriate team where necessary with detailed notes on investigation of the issue. Find opportunities for service improvement and engage the relevant teams to reduce Service Desk time taken to resolve/escalate Incidents & Requests. Assist all other Service Desk team members in following Novotech Service Desk SOP s and highlight to line management where additional training or clarifications are required. Fluent written and verbal English. Service Desk Analysts may have additional verbal and written fluency requirements based on the location they are initially hired into: Service Desk Analysts hired in Taiwan / China mainland will be required to have written and verbal fluency in Mandarin. Service Desk Analysts hired in Korea will be required to have written and verbal fluency in Korean / Hangul. Service Desk Operation Installation of hardware and software based on the documented processes within the knowledge base. In office-based locations, attend the sites either according to a schedule or ad-hoc arrangement, as directed by the team lead, with an expectation of 3 days in the office under a hybrid model. Manage local stock rooms, including reporting on current stock volumes and ordering of new stock to meet anticipated demand. Respond to incoming events in a timely manner in line with KPIs and SLAs. Update and resolve events received by the Service Desk team in a timely manner in line with KPIs and SLAs. Using the Novotech Service Desk Ticket system to record all data regarding day-to-day tasks. Self-logging of tasks completed outside of the scope of the ticket is required. E.g. walk-up, IM or telephone. Maintain accurate records and documentation of all interactions and resolutions within the Service Desk ticketing system, ensuring compliance with data protection and confidentiality guidelines. Provide training documentation and training sessions to non-IT staff on use of IT Systems and general Novotech setup. About the role: The IT Service Desk Analyst works within the IT department and is responsible for ensuring that efficient and effective responses to requests for day-to-day technical advice and support to internal employees and systems. The role will need to display a high level of competency in customer service, technical troubleshooting, and record keeping, to ensure customers receive the help required, and downstream teams receive the data they require. The IT Service Desk Analyst performs both virtual support for all global Novotech staff, and Office/Desktop support for the office they work from. The IT Analyst is expected to pro-actively look for ways to improve IT Service Delivery, whether through new processes or new technology, and work to implement those improvements in the company. There may be requirements to assist with IT Projects being run by other teams or senior team members. Minimum Qualifications & Experience: Strong customer service skills. Strong verbal and written communication skills. Strong skills in MS Office, Active Directory/Azure, Windows OS, Exchange user management. ITIL V4 Foundations. MSDST, CCNP, or MCDST certification desirable. Responsibilities: The responsibilities will vary day to day and may include: Works within the IT service desk team to provide speedy and efficient resolution of Service Desk tickets/calls via Service Desk ticket review and Service Desk system stats in line with SLAs. Help develop processes to reduce time taken to resolve Service Desk issues. Identify knowledge base gaps through daily ticket review. Create and update Novotech Service Desk SOP s/Knowledge Base. Adhere to all published Policies, SOP s, DOP s, WIs, and Knowledge Base Articles. Highlight & escalate any conflicts between these documents to your line manager and document in related tickets. Actively participate in continual service improvement programs (i.e. knowledge discovery & documentation, process improvement, technology discovery & implementation etc). Escalate to the appropriate team where necessary with detailed notes on investigation of the issue. Find opportunities for service improvement and engage the relevant teams to reduce Service Desk time taken to resolve/escalate Incidents & Requests. Assist all other Service Desk team members in following Novotech Service Desk SOP s and highlight to line management where additional training or clarifications are required. Fluent written and verbal English. Service Desk Operation Installation of hardware and software based on the documented processes within the knowledge base. In office-based locations, attend the sites either according to a schedule or ad-hoc arrangement, as directed by the team lead, with an expectation of 3 days in the office under a hybrid model. Manage local stock rooms, including reporting on current stock volumes and ordering of new stock to meet anticipated demand. Respond to incoming events in a timely manner in line with KPIs and SLAs. Update and resolve events received by the Service Desk team in a timely manner in line with KPIs and SLAs. Using the Novotech Service Desk Ticket system to record all data regarding day-to-day tasks. Self-logging of tasks completed outside of the scope of the ticket is required. E.g. walk-up, IM or telephone. Maintain accurate records and documentation of all interactions and resolutions within the Service Desk ticketing system, ensuring compliance with data protection and confidentiality guidelines. Provide training documentation and training sessions to non-IT staff on use of IT Systems and general Novotech setup. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: Strong customer service skills. Strong verbal and written communication skills. Strong skills in MS Office, Active Directory/Azure, Windows OS, Exchange user management. ITIL V4 Foundations. MSDST, CCNP, or MCDST certification desirable. Responsibilities: The responsibilities will vary day to day and may include: Works within the IT service desk team to provide speedy and efficient resolution of Service Desk tickets/calls via Service Desk ticket review and Service Desk system stats in line with SLAs. Help develop processes to reduce time taken to resolve Service Desk issues. Identify knowledge base gaps through daily ticket review. Create and update Novotech Service Desk SOP s/Knowledge Base. Adhere to all published Policies, SOP s, DOP s, WIs, and Knowledge Base Articles. Highlight & escalate any conflicts between these documents to your line manager and document in related tickets. Actively participate in continual service improvement programs (i.e. knowledge discovery & documentation, process improvement, technology discovery & implementation etc). Escalate to the appropriate team where necessary with detailed notes on investigation of the issue. Find opportunities for service improvement and engage the relevant teams to reduce Service Desk time taken to resolve/escalate Incidents & Requests. Assist all other Service Desk team members in following Novotech Service Desk SOP s and highlight to line management where additional training or clarifications are required. Fluent written and verbal English. Service Desk Analysts may have additional verbal and written fluency requirements based on the location they are initially hired into: Service Desk Analysts hired in Taiwan / China mainland will be required to have written and verbal fluency in Mandarin. Service Desk Analysts hired in Korea will be required to have written and verbal fluency in Korean / Hangul. Service Desk Operation Installation of hardware and software based on the documented processes within the knowledge base. In office-based locations, attend the sites either according to a schedule or ad-hoc arrangement, as directed by the team lead, with an expectation of 3 days in the office under a hybrid model. Manage local stock rooms, including reporting on current stock volumes and ordering of new stock to meet anticipated demand. Respond to incoming events in a timely manner in line with KPIs and SLAs. Update and resolve events received by the Service Desk team in a timely manner in line with KPIs and SLAs. Using the Novotech Service Desk Ticket system to record all data regarding day-to-day tasks. Self-logging of tasks completed outside of the scope of the ticket is required. E.g. walk-up, IM or telephone. Maintain accurate records and documentation of all interactions and resolutions within the Service Desk ticketing system, ensuring compliance with data protection and confidentiality guidelines. Provide training documentation and training sessions to non-IT staff on use of IT Systems and general Novotech setup.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 2.0 - 4.0 Lacs P.A.
Work from Office
Full Time
About the role: The Investigator Grants Specialist will provide support to project team in managing the payment for investigators and developing the Investigator grant using the standard system such as Grant Plan. This role will be closely working with Project Management and Clinical Operations team to ensure timely delivery of site budget templates and to process site payments every quarter with assistance of project team. All activities are performed according to the Novotech s/Client SOP and guidelines. The ideal candidate will be professional, analytical and possess excellent written and verbal communication skills Minimum Qualifications & Experience: At least 12-36 months of experience in a clinical research organization or equivalent. Minimum Batchelor s degree in Life science or related field Experience working in Investigator Payment Process. Experience working in CTMS/Veeva. Experience working in Grant Plan. Understanding of Subject Visit Tracking in CTMS. Strong hold on excel and Power Point (MS). Good communication skills. Must have analytical, problem solving, Excellent verbal and written communication and negotiation skills. Excellent interpersonal and relationship building skills. Extremely well organized and detailed oriented with demonstrated follow-up skills. Candidate should have prior background in the pharmaceutical, CRO or healthcare industry. Responsibilities: Investigator Payment Activity To review, update and track all payments in CTMS appropriately. To route correspondence appropriately and ensure all queries raised have been assigned to the correct team member in a timely manner. To escalate payment issues/delays appropriately. To review payments in line with visit data in CTMS to ensure sites are being paid timely accurate and efficient manner and escalate delays/ issues appropriately. Communicate effectively with Project Managers, regarding payment enquiries and managing their expectations accordingly. To support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract. Assists with maintaining schedule for patient visit payments per contract with the Sponsor and the Site. Process all site payments for patient visits. Review the site payment report based on the required due date for payments to be made to make sure the report is correct and free of errors before processing any payments. Prepare Investigator Payment report for study status meetings as requested by Project Manager. Be accountable for the quality of how each study assigned is set-up and maintained, ensuring payments are correct and that all work carried out is in accordance with Investigator Payment processes and procedures and is audit Analyze and assess SVT setup requirement based on study type (simple/complex/cohort). Create site SVTs based on CTRAs received from CRAs. Setup Master/Site specific SVT templates in CTMS within the required timelines and ensure accurate templates are built in before release to study teams. Be aware of and adhere to company processes in areas relevant to Investigator Grant Specialist. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out IGS role. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Investigator Grants Activity: Responsible for the development of investigator grant using industry standard systems. Review study protocols work closely with Project Managers to ensure accurate, complete, and timely deliveries of Investigator Grants. Candidate will be assigned in the complex projects Provide initial budget estimates as requested by clients. Apply Industry standard of care concepts into building budget model. Address questions related to Fair Market Value. Communicate with vendor for system related issues. Manage list of user access to required systems. Track finalized budgets and ensured reporting as required. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: At least 12-36 months of experience in a clinical research organization or equivalent. Minimum Batchelor s degree in Life science or related field Experience working in Investigator Payment Process. Experience working in CTMS/Veeva. Experience working in Grant Plan. Understanding of Subject Visit Tracking in CTMS. Strong hold on excels and Power Point (MS). Effective communication skills. Must have analytical, problem solving, Excellent verbal and written communication and negotiation skills. Excellent interpersonal and relationship building skills. Extremely well organized and detailed oriented with demonstrated follow-up skills. Should have prior background in the pharmaceutical, CRO or healthcare industry. Responsibilities: Investigator Payment Activity To review, update and track all payments in CTMS appropriately. To route correspondence appropriately and ensure all queries raised have been assigned to the correct team member in a timely manner. To escalate payment issues/delays appropriately. To review payments in line with visit data in CTMS to ensure sites are being paid timely accurate and efficient manner and escalate delays/ issues appropriately. Communicate effectively with Project Managers, regarding payment enquiries and managing their expectations accordingly. To support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract. Assists with maintaining schedule for patient visit payments per contract with the Sponsor and the Site. Process all site payments for patient visits. Review the site payment report based on the required due date for payments to be made to make sure the report is correct and free of errors before processing any payments. Prepare Investigator Payment report for study status meetings as requested by Project Manager. Be accountable for the quality of how each study assigned is set-up and maintained, ensuring payments are correct and that all work carried out is in accordance with Investigator Payment processes and procedures and is audit Analyze and assess SVT setup requirement based on study type (simple/complex/cohort). Create site SVTs based on CTRAs received from CRAs. Setup Master/Site specific SVT templates in CTMS within the required timelines and ensure accurate templates are built in before release to study teams. Be aware of and adhere to company processes in areas relevant to Investigator Grant Specialist. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out IGS role. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Investigator Grants Activity: Responsible for the development of investigator grant using industry standard systems. Review study protocols work closely with Project Managers to ensure accurate, complete, and timely deliveries of Investigator Grants. Candidate will be assigned in the complex projects Provide initial budget estimates as requested by clients. Apply Industry standard of care concepts into building budget model. Address questions related to Fair Market Value. Communicate with vendor for system related issues. Manage list of user access to required systems. Track finalized budgets and ensured reporting as required. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. About the role: The Investigator Grants Specialist will provide support to project team in managing the payment for investigators and developing the Investigator grant using the standard system such as Grant Plan. This role will be closely working with Project Management and Clinical Operations team to ensure timely delivery of site budget templates and to process site payments every quarter with assistance of project team. All activities are performed according to the Novotech s/Client SOP and guidelines. The ideal candidate will be professional, analytical and possess excellent written and verbal communication skills Minimum Qualifications & Experience: At least 12-36 months of experience in a clinical research organization or equivalent. Minimum Batchelor s degree in Life science or related field Experience working in Investigator Payment Process. Experience working in CTMS/Veeva. Experience working in Grant Plan. Understanding of Subject Visit Tracking in CTMS. Strong hold on excel and Power Point (MS). Good communication skills. Must have analytical, problem solving, Excellent verbal and written communication and negotiation skills. Excellent interpersonal and relationship building skills. Extremely well organized and detailed oriented with demonstrated follow-up skills. Candidate should have prior background in the pharmaceutical, CRO or healthcare industry. Responsibilities: Investigator Payment Activity To review, update and track all payments in CTMS appropriately. To route correspondence appropriately and ensure all queries raised have been assigned to the correct team member in a timely manner. To escalate payment issues/delays appropriately. To review payments in line with visit data in CTMS to ensure sites are being paid timely accurate and efficient manner and escalate delays/ issues appropriately. Communicate effectively with Project Managers, regarding payment enquiries and managing their expectations accordingly. To support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract. Assists with maintaining schedule for patient visit payments per contract with the Sponsor and the Site. Process all site payments for patient visits. Review the site payment report based on the required due date for payments to be made to make sure the report is correct and free of errors before processing any payments. Prepare Investigator Payment report for study status meetings as requested by Project Manager. Be accountable for the quality of how each study assigned is set-up and maintained, ensuring payments are correct and that all work carried out is in accordance with Investigator Payment processes and procedures and is audit Analyze and assess SVT setup requirement based on study type (simple/complex/cohort). Create site SVTs based on CTRAs received from CRAs. Setup Master/Site specific SVT templates in CTMS within the required timelines and ensure accurate templates are built in before release to study teams. Be aware of and adhere to company processes in areas relevant to Investigator Grant Specialist. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out IGS role. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Investigator Grants Activity: Responsible for the development of investigator grant using industry standard systems. Review study protocols work closely with Project Managers to ensure accurate, complete, and timely deliveries of Investigator Grants. Candidate will be assigned in the complex projects Provide initial budget estimates as requested by clients. Apply Industry standard of care concepts into building budget model. Address questions related to Fair Market Value. Communicate with vendor for system related issues. Manage list of user access to required systems. Track finalized budgets and ensured reporting as required. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: At least 12-36 months of experience in a clinical research organization or equivalent. Minimum Batchelor s degree in Life science or related field Experience working in Investigator Payment Process. Experience working in CTMS/Veeva. Experience working in Grant Plan. Understanding of Subject Visit Tracking in CTMS. Strong hold on excels and Power Point (MS). Effective communication skills. Must have analytical, problem solving, Excellent verbal and written communication and negotiation skills. Excellent interpersonal and relationship building skills. Extremely well organized and detailed oriented with demonstrated follow-up skills. Should have prior background in the pharmaceutical, CRO or healthcare industry. Responsibilities: Investigator Payment Activity To review, update and track all payments in CTMS appropriately. To route correspondence appropriately and ensure all queries raised have been assigned to the correct team member in a timely manner. To escalate payment issues/delays appropriately. To review payments in line with visit data in CTMS to ensure sites are being paid timely accurate and efficient manner and escalate delays/ issues appropriately. Communicate effectively with Project Managers, regarding payment enquiries and managing their expectations accordingly. To support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract. Assists with maintaining schedule for patient visit payments per contract with the Sponsor and the Site. Process all site payments for patient visits. Review the site payment report based on the required due date for payments to be made to make sure the report is correct and free of errors before processing any payments. Prepare Investigator Payment report for study status meetings as requested by Project Manager. Be accountable for the quality of how each study assigned is set-up and maintained, ensuring payments are correct and that all work carried out is in accordance with Investigator Payment processes and procedures and is audit Analyze and assess SVT setup requirement based on study type (simple/complex/cohort). Create site SVTs based on CTRAs received from CRAs. Setup Master/Site specific SVT templates in CTMS within the required timelines and ensure accurate templates are built in before release to study teams. Be aware of and adhere to company processes in areas relevant to Investigator Grant Specialist. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out IGS role. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. Investigator Grants Activity: Responsible for the development of investigator grant using industry standard systems. Review study protocols work closely with Project Managers to ensure accurate, complete, and timely deliveries of Investigator Grants. Candidate will be assigned in the complex projects Provide initial budget estimates as requested by clients. Apply Industry standard of care concepts into building budget model. Address questions related to Fair Market Value. Communicate with vendor for system related issues. Manage list of user access to required systems. Track finalized budgets and ensured reporting as required. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 8.0 - 12.0 Lacs P.A.
Work from Office
Full Time
About the opportunity: The Clinical Systems Training Specialist will support the creation, maintenance, and delivery of high-quality training materials for our Veeva Clinical systems. The candidate should have knowledge of e-learning / instructional design tools, video editing, SharePoint content management, and Veeva Clinical applications. Minimum Qualifications & Experience: Experience using Veeva Clinical platform preferred Working knowledge of Articulate storyline, Camtasia, Visio, SP will be preferred, but not mandatory Good Training delivery skills L&D qualification strongly regarded, but not mandatory. A good understanding of clinical research processes and terminology. Responsibilities: Support development of engaging training content using tools like Articulate Storyline, Camtasia, Natural Reader, and similar. Create and maintain quick reference guides, training videos, FAQs, and workflows for all applicable Veeva Clinical systems. Deliver training across multiple time zones as per the training calendar and upon workflow updates. Collaborate with subject matter experts to translate system processes into clear, interactive training materials. Create system process workflows using Microsoft Visio or similar tools to support other learning materials. Record, edit, and produce professional-quality training videos and voiceovers. Update and manage SharePoint training sites/pages, including formatting content and uploading new material. Support the development and rollout of training courses for both internal employees and external stakeholders. Assist in managing a training calendar, tracking content updates, and maintaining version control of all training assets. Support training delivery that may occur outside of standard office hours. Continuously review and enhance training materials based on user feedback and system updates. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. About the opportunity: The Clinical Systems Training Specialist will support the creation, maintenance, and delivery of high-quality training materials for our Veeva Clinical systems. The candidate should have knowledge of e-learning / instructional design tools, video editing, SharePoint content management, and Veeva Clinical applications. Minimum Qualifications & Experience: Experience using Veeva Clinical platform preferred Working knowledge of Articulate storyline, Camtasia, Visio, SP will be preferred, but not mandatory Good Training delivery skills L&D qualification strongly regarded, but not mandatory. A good understanding of clinical research processes and terminology. Responsibilities: Support development of engaging training content using tools like Articulate Storyline, Camtasia, Natural Reader, and similar. Create and maintain quick reference guides, training videos, FAQs, and workflows for all applicable Veeva Clinical systems. Deliver training across multiple time zones as per the training calendar and upon workflow updates. Collaborate with subject matter experts to translate system processes into clear, interactive training materials. Create system process workflows using Microsoft Visio or similar tools to support other learning materials. Record, edit, and produce professional-quality training videos and voiceovers. Update and manage SharePoint training sites/pages, including formatting content and uploading new material. Support the development and rollout of training courses for both internal employees and external stakeholders. Assist in managing a training calendar, tracking content updates, and maintaining version control of all training assets. Support training delivery that may occur outside of standard office hours. Continuously review and enhance training materials based on user feedback and system updates. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 4.0 - 8.0 Lacs P.A.
Work from Office
Full Time
About the role: The Senior Accounts Receivable Specialist is primarily responsible for all internal and external customers of Novotech and coordinating with associates with the AR team. Provides financial support by ensuring the company receives payments for services and managing the process of recording the transactions by posting receipts and resolving discrepancies according to established policies and procedures in an efficient, timely and accurate manner. Regular follow up with customers to ensure all invoices processed and paid in timely manner. Responsibilities: Help with the process of preparing, verifying, and processing invoices for services rendered. Collaborate the process of collections on accounts by sending invoice reminders and communication with customers via phone, email, fax, or mail. Work with team involved in customer payments, recording cash, checks, and Wire transactions, and entering them into the general ledger or accounting software. Resolve collections by examining customer payment plans, payment history, credit line. Generate monthly, quarterly, or annual financial statements and reports detailing paid and unpaid invoices and other accounts receivable activity. Protect organization s value by keeping information confidential. Collection management, including reviewing credit memos or revised invoices. Participate in process improvements and efficiency into the AR function, ensuring common processes are applied to all agencies and leading practices are adopted through staff training and system enhancements. Minimum Qualifications & Experience: Strong hold on Excel and Power Point (MS). Candidate must be a pro-active self-starter with a dynamic and resilient nature working in a fast- paced, challenging environment. Must have analytical, problem solving. Excellent interpersonal and relationship building skills. Extremely well organized and detailed oriented with demonstrated follow-up skills. Strong Financial aptitude. Proficient in PC applications to include MS Word, Excel, and PowerPoint. Experience in Net Suite will be added advantage. 6-8 years of relevant experience in a professional work environment with a minimum of 4 years experience in Accounts Receivable. Keen eye for process and quality improvement. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. About the role: The Senior Accounts Receivable Specialist is primarily responsible for all internal and external customers of Novotech and coordinating with associates with the AR team. Provides financial support by ensuring the company receives payments for services and managing the process of recording the transactions by posting receipts and resolving discrepancies according to established policies and procedures in an efficient, timely and accurate manner. Regular follow up with customers to ensure all invoices processed and paid in timely manner. Responsibilities: Help with the process of preparing, verifying, and processing invoices for services rendered. Collaborate the process of collections on accounts by sending invoice reminders and communication with customers via phone, email, fax, or mail. Work with team involved in customer payments, recording cash, checks, and Wire transactions, and entering them into the general ledger or accounting software. Resolve collections by examining customer payment plans, payment history, credit line. Generate monthly, quarterly, or annual financial statements and reports detailing paid and unpaid invoices and other accounts receivable activity. Protect organization s value by keeping information confidential. Collection management, including reviewing credit memos or revised invoices. Participate in process improvements and efficiency into the AR function, ensuring common processes are applied to all agencies and leading practices are adopted through staff training and system enhancements. Minimum Qualifications & Experience: Strong hold on Excel and Power Point (MS). Candidate must be a pro-active self-starter with a dynamic and resilient nature working in a fast- paced, challenging environment. Must have analytical, problem solving. Excellent interpersonal and relationship building skills. Extremely well organized and detailed oriented with demonstrated follow-up skills. Strong Financial aptitude. Proficient in PC applications to include MS Word, Excel, and PowerPoint. Experience in Net Suite will be added advantage. 6-8 years of relevant experience in a professional work environment with a minimum of 4 years experience in Accounts Receivable. Keen eye for process and quality improvement. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 9.0 - 13.0 Lacs P.A.
Work from Office
Full Time
About the role: The Senior Finance Specialist is responsible for managing employee expense claims, ensuring compliance with company policies, and administering the corporate card program. This role requires attention to detail, a strong understanding of financial controls, and excellent customer service skills to support employees with their claims and card-related queries. Minimum Qualifications & Experience: Bachelor s degree in accounting, Finance, Business Administration, or a related field. 6+ years of experience in expense claims processing, accounts payable, or corporate card administration. Proficiency in Concur and Certinia system, MS Excel, and financial reporting tools. Strong attention to detail, problem-solving abilities, and excellent communication skills. Familiarity with corporate expense policies, tax implications, and financial compliance. Experience working in a shared services or multinational environment. Prior experience with corporate card programs and expense management tools. Ability to handle confidential information with integrity and discretion. Responsibilities: Expense Claims Processing: Review and process employee expense claims in accordance with company policies and guidelines. Ensure receipts and supporting documents comply with company policies and requirements. Verify approvals and escalate non-compliant claims to management. Coordinate with employees to resolve discrepancies or missing documentation. Process reimbursements through the Certinia system and liaise with Accounts Payable for timely payments. Assist in monthly expense accruals and reporting. Support Concur Technical team lead for new entity roll out and system enhancement initiatives. Stay updated on new Concur enhancements, features, and industry best practices, and proactively implement improvements to the system Manage helpdesk tickets, resolve user issues, and escalate problems as needed to ensure timely resolution. Corporate Card Administration: Manage the issuance, renewal, and cancellation of corporate credit cards. Maintain corporate cardholder records and ensure adherence to company policies. Monitor transactions for policy violations and follow up with employees as needed. Reconcile corporate card statements and ensure timely settlements. Support employees with card-related inquiries, including lost/stolen card replacements. Collaborate with the bank or card provider for troubleshooting and program enhancements. Compliance & Reporting: Ensure compliance with company policies, tax regulations, and audit requirements. Generate and analyse expense reports to identify trends, policy violations, and cost-saving opportunities. Assist in audits by providing required documentation and explanations. Recommend process improvements to enhance efficiency and reduce errors. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. About the role: The Senior Finance Specialist is responsible for managing employee expense claims, ensuring compliance with company policies, and administering the corporate card program. This role requires attention to detail, a strong understanding of financial controls, and excellent customer service skills to support employees with their claims and card-related queries. Minimum Qualifications & Experience: Bachelor s degree in accounting, Finance, Business Administration, or a related field. 6+ years of experience in expense claims processing, accounts payable, or corporate card administration. Proficiency in Concur and Certinia system, MS Excel, and financial reporting tools. Strong attention to detail, problem-solving abilities, and excellent communication skills. Familiarity with corporate expense policies, tax implications, and financial compliance. Experience working in a shared services or multinational environment. Prior experience with corporate card programs and expense management tools. Ability to handle confidential information with integrity and discretion. Responsibilities: Expense Claims Processing: Review and process employee expense claims in accordance with company policies and guidelines. Ensure receipts and supporting documents comply with company policies and requirements. Verify approvals and escalate non-compliant claims to management. Coordinate with employees to resolve discrepancies or missing documentation. Process reimbursements through the Certinia system and liaise with Accounts Payable for timely payments. Assist in monthly expense accruals and reporting. Support Concur Technical team lead for new entity roll out and system enhancement initiatives. Stay updated on new Concur enhancements, features, and industry best practices, and proactively implement improvements to the system Manage helpdesk tickets, resolve user issues, and escalate problems as needed to ensure timely resolution. Corporate Card Administration: Manage the issuance, renewal, and cancellation of corporate credit cards. Maintain corporate cardholder records and ensure adherence to company policies. Monitor transactions for policy violations and follow up with employees as needed. Reconcile corporate card statements and ensure timely settlements. Support employees with card-related inquiries, including lost/stolen card replacements. Collaborate with the bank or card provider for troubleshooting and program enhancements. Compliance & Reporting: Ensure compliance with company policies, tax regulations, and audit requirements. Generate and analyse expense reports to identify trends, policy violations, and cost-saving opportunities. Assist in audits by providing required documentation and explanations. Recommend process improvements to enhance efficiency and reduce errors. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 5.0 - 9.0 Lacs P.A.
Work from Office
Full Time
About the Opportunity: We are seeking an experienced Oracle Fusion HCM Specialist to manage, implement, and optimize our Oracle Fusion Human Capital Management (HCM) system. The ideal candidate should have expertise in HCM modules, system configurations, reporting, and troubleshooting to ensure efficient HR operations and compliance with business requirements. Required Qualifications & Skills: Bachelor s degree in Information Technology or a related field. Minimum 3-5 years of experience working with Oracle Fusion HCM, preferably in an implementation or support role. Strong understanding of HR processes and best practices. Experience in Oracle HCM modules such as Core HR, Absence, Talent Management, Benefits, and Compensation. Knowledge of HCM Data Loader (HDL), Fast Formulas, BI Publisher, and Oracle Reporting Tools. Familiarity with security roles, workflows, and approval configurations within Oracle HCM. Strong problem-solving skills with the ability to troubleshoot and resolve system issues. Excellent communication and stakeholder management skills. Key Responsibilities: Configure, implement, and support Oracle Fusion HCM modules, including Core HR, Talent Management, Absence Management, Benefits, and Compensation. Act as the primary point of contact for system enhancements, troubleshooting, and resolving technical issues. Collaborate with HR, IT, and other business stakeholders to gather requirements and develop solutions that optimize HR processes. Perform system testing, validation, and maintenance to ensure data integrity and system performance. Develop and maintain Oracle HCM reports, dashboards, and analytics to support decision-making. Provide end-user training and support to HR teams and other system users. Ensure compliance with company policies, industry regulations, and data security best practices. Work with Oracle Support and external vendors to address system-related issues and upgrades. Stay updated with Oracle HCM Cloud updates and implement new features as needed. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and committed to respond to every application. We look forward to connecting with you regarding your application. About the Opportunity: We are seeking an experienced Oracle Fusion HCM Specialist to manage, implement, and optimize our Oracle Fusion Human Capital Management (HCM) system. The ideal candidate should have expertise in HCM modules, system configurations, reporting, and troubleshooting to ensure efficient HR operations and compliance with business requirements. Required Qualifications & Skills: Bachelor s degree in Information Technology or a related field. Minimum 3-5 years of experience working with Oracle Fusion HCM, preferably in an implementation or support role. Strong understanding of HR processes and best practices. Experience in Oracle HCM modules such as Core HR, Absence, Talent Management, Benefits, and Compensation. Knowledge of HCM Data Loader (HDL), Fast Formulas, BI Publisher, and Oracle Reporting Tools. Familiarity with security roles, workflows, and approval configurations within Oracle HCM. Strong problem-solving skills with the ability to troubleshoot and resolve system issues. Excellent communication and stakeholder management skills. Key Responsibilities: Configure, implement, and support Oracle Fusion HCM modules, including Core HR, Talent Management, Absence Management, Benefits, and Compensation. Act as the primary point of contact for system enhancements, troubleshooting, and resolving technical issues. Collaborate with HR, IT, and other business stakeholders to gather requirements and develop solutions that optimize HR processes. Perform system testing, validation, and maintenance to ensure data integrity and system performance. Develop and maintain Oracle HCM reports, dashboards, and analytics to support decision-making. Provide end-user training and support to HR teams and other system users. Ensure compliance with company policies, industry regulations, and data security best practices. Work with Oracle Support and external vendors to address system-related issues and upgrades. Stay updated with Oracle HCM Cloud updates and implement new features as needed. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and committed to respond to every application. We look forward to connecting with you regarding your application.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 4.0 - 9.0 Lacs P.A.
Work from Office
Full Time
About the role: The Senior Document Management Associate (SDMA) will provide support for Trial Master File (TMF) activities to the clinical teams for all assigned projects. This role will be responsible for working with study teams, both internal and external, to manage both paper and electronic Trial Master Files (TMF), according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs. The SDMA will also be responsible for performing comprehensive QC reviews. Minimum Qualifications & Experience: At least more than 2 years of experience in a clinical research organization or equivalent role. Practical experience in handling Trial Master File activities including paper or electronic-TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. Responsibilities 1. Senior DMA will have a dual responsibility of working on document upload and document QC processes. 2. Senior DMA will also play an important role in mentoring and training the new DMA team. SDMA as a document uploader 1. Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs. 2. DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs. 3. DMA will review each document as received for completeness and quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality. 4. DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner. 5. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project. 6. Ensure the TMF is inspection ready at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines. 7. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance. 8. Prepares monthly reports to ensure accuracy of the files and provides to the project teams. 9. Prepares the TMF for delivery at study closeout. 10. Reviews and prepares the TMF for audits and TMF reviews; Provide support to the project team during audits and/or regulatory inspections. 11. Resolves any internal quality control findings and audit findings. 12. Runs and maintains department reports. 13. Creates checklists and daily quality control schedules. 14. Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. 15. Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role. 16. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. 17. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. SDMA as a QC reviewer. 1. Senior DMA will work closely with Central Filing Team Lead for assignment of projects for QC review. 2. Ensure all assigned project QC review are performed after every quarter or as per the study plan. 3. Senior DMA will be preparing a QC checklist and shared with project team to resolve and track any queries. 4. Senior DMA will ensure that all queries are responded within the stipulated timeline. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: At least more than 2 years of experience in a clinical research organization or equivalent role. Practical experience in handling Trial Master File activities including paper or electronic-TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. Responsibilities 1. Senior DMA will have a dual responsibility of working on document upload and document QC processes. 2. Senior DMA will also play an important role in mentoring and training the new DMA team. SDMA as a document uploader 1. Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs. 2. DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs. 3. DMA will review each document as received for completeness and quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality. 4. DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner. 5. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project. 6. Ensure the TMF is inspection ready at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines. 7. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance. 8. Prepares monthly reports to ensure accuracy of the files and provides to the project teams. 9. Prepares the TMF for delivery at study closeout. 10. Reviews and prepares the TMF for audits and TMF reviews; Provide support to the project team during audits and/or regulatory inspections. 11. Resolves any internal quality control findings and audit findings. 12. Runs and maintains department reports. 13. Creates checklists and daily quality control schedules. 14. Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. 15. Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role. 16. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. 17. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. SDMA as a QC reviewer. 1. Senior DMA will work closely with Central Filing Team Lead for assignment of projects for QC review. 2. Ensure all assigned project QC review are performed after every quarter or as per the study plan. 3. Senior DMA will be preparing a QC checklist and shared with project team to resolve and track any queries. 4. Senior DMA will ensure that all queries are responded within the stipulated timeline.
Kolkata, Mumbai, New Delhi, Hyderabad, Pune, Chennai, Bengaluru
INR 4.0 - 9.0 Lacs P.A.
Work from Office
Full Time
About the role: The Senior Document Management Associate (SDMA) will provide support for Trial Master File (TMF) activities to the clinical teams for all assigned projects. This role will be responsible for working with study teams, both internal and external, to manage both paper and electronic Trial Master Files (TMF), according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs. The SDMA will also be responsible for performing comprehensive QC reviews. Minimum Qualifications & Experience: At least more than 2 years of experience in a clinical research organization or equivalent role. Practical experience in handling Trial Master File activities including paper or electronic-TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. Responsibilities 1. Senior DMA will have a dual responsibility of working on document upload and document QC processes. 2. Senior DMA will also play an important role in mentoring and training the new DMA team. SDMA as a document uploader 1. Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs. 2. DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs. 3. DMA will review each document as received for completeness and quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality. 4. DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner. 5. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project. 6. Ensure the TMF is inspection ready at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines. 7. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance. 8. Prepares monthly reports to ensure accuracy of the files and provides to the project teams. 9. Prepares the TMF for delivery at study closeout. 10. Reviews and prepares the TMF for audits and TMF reviews; Provide support to the project team during audits and/or regulatory inspections. 11. Resolves any internal quality control findings and audit findings. 12. Runs and maintains department reports. 13. Creates checklists and daily quality control schedules. 14. Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. 15. Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role. 16. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. 17. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. SDMA as a QC reviewer. 1. Senior DMA will work closely with Central Filing Team Lead for assignment of projects for QC review. 2. Ensure all assigned project QC review are performed after every quarter or as per the study plan. 3. Senior DMA will be preparing a QC checklist and shared with project team to resolve and track any queries. 4. Senior DMA will ensure that all queries are responded within the stipulated timeline. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: At least more than 2 years of experience in a clinical research organization or equivalent role. Practical experience in handling Trial Master File activities including paper or electronic-TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. Responsibilities 1. Senior DMA will have a dual responsibility of working on document upload and document QC processes. 2. Senior DMA will also play an important role in mentoring and training the new DMA team. SDMA as a document uploader 1. Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs. 2. DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs. 3. DMA will review each document as received for completeness and quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality. 4. DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner. 5. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project. 6. Ensure the TMF is inspection ready at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines. 7. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance. 8. Prepares monthly reports to ensure accuracy of the files and provides to the project teams. 9. Prepares the TMF for delivery at study closeout. 10. Reviews and prepares the TMF for audits and TMF reviews; Provide support to the project team during audits and/or regulatory inspections. 11. Resolves any internal quality control findings and audit findings. 12. Runs and maintains department reports. 13. Creates checklists and daily quality control schedules. 14. Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. 15. Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role. 16. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. 17. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. SDMA as a QC reviewer. 1. Senior DMA will work closely with Central Filing Team Lead for assignment of projects for QC review. 2. Ensure all assigned project QC review are performed after every quarter or as per the study plan. 3. Senior DMA will be preparing a QC checklist and shared with project team to resolve and track any queries. 4. Senior DMA will ensure that all queries are responded within the stipulated timeline. About the role: The Senior Document Management Associate (SDMA) will provide support for Trial Master File (TMF) activities to the clinical teams for all assigned projects. This role will be responsible for working with study teams, both internal and external, to manage both paper and electronic Trial Master Files (TMF), according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs. The SDMA will also be responsible for performing comprehensive QC reviews. Minimum Qualifications & Experience: At least more than 2 years of experience in a clinical research organization or equivalent role. Practical experience in handling Trial Master File activities including paper or electronic-TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. Responsibilities 1. Senior DMA will have a dual responsibility of working on document upload and document QC processes. 2. Senior DMA will also play an important role in mentoring and training the new DMA team. SDMA as a document uploader 1. Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs. 2. DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs. 3. DMA will review each document as received for completeness and quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality. 4. DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner. 5. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project. 6. Ensure the TMF is inspection ready at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines. 7. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance. 8. Prepares monthly reports to ensure accuracy of the files and provides to the project teams. 9. Prepares the TMF for delivery at study closeout. 10. Reviews and prepares the TMF for audits and TMF reviews; Provide support to the project team during audits and/or regulatory inspections. 11. Resolves any internal quality control findings and audit findings. 12. Runs and maintains department reports. 13. Creates checklists and daily quality control schedules. 14. Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. 15. Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role. 16. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. 17. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. SDMA as a QC reviewer. 1. Senior DMA will work closely with Central Filing Team Lead for assignment of projects for QC review. 2. Ensure all assigned project QC review are performed after every quarter or as per the study plan. 3. Senior DMA will be preparing a QC checklist and shared with project team to resolve and track any queries. 4. Senior DMA will ensure that all queries are responded within the stipulated timeline. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Minimum Qualifications & Experience: At least more than 2 years of experience in a clinical research organization or equivalent role. Practical experience in handling Trial Master File activities including paper or electronic-TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. Responsibilities 1. Senior DMA will have a dual responsibility of working on document upload and document QC processes. 2. Senior DMA will also play an important role in mentoring and training the new DMA team. SDMA as a document uploader 1. Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs. 2. DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs. 3. DMA will review each document as received for completeness and quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality. 4. DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner. 5. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project. 6. Ensure the TMF is inspection ready at all times and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines. 7. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance. 8. Prepares monthly reports to ensure accuracy of the files and provides to the project teams. 9. Prepares the TMF for delivery at study closeout. 10. Reviews and prepares the TMF for audits and TMF reviews; Provide support to the project team during audits and/or regulatory inspections. 11. Resolves any internal quality control findings and audit findings. 12. Runs and maintains department reports. 13. Creates checklists and daily quality control schedules. 14. Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. 15. Be aware of and adhere to company processes in areas relevant to a DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA role. 16. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. 17. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company. SDMA as a QC reviewer. 1. Senior DMA will work closely with Central Filing Team Lead for assignment of projects for QC review. 2. Ensure all assigned project QC review are performed after every quarter or as per the study plan. 3. Senior DMA will be preparing a QC checklist and shared with project team to resolve and track any queries. 4. Senior DMA will ensure that all queries are responded within the stipulated timeline.
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