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5.0 - 8.0 years

0 Lacs

Hyderabad, Telangana, India

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Role: Clinical Operations Support Required Technical Skill Set: Highly skilled with Veeva eTMF Application Experience: 5 to 8 Years Work Location: Mumbai, New Delhi, Indore, Bangalore , Hyderabad, Pune, Lucknow, Chennai, Kolkata Desired Competencies (Technical/Behavioral Competency) Must-Have: Experience with R&D specific IT application systems for Document management, trial management, Data management and/or Pharmacovigilance. Experience with data visualization and/or analytics tools and ability to build, program and modify new reports and visualizations. Experience with Clinical Trial related systems, e.g. Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF, preferably Veeva Vault), Electronic Data Capture (EDC, preferably Medidata RAVE) and Large Scale Data Analytics (such as SpotFire, CluePoints, JReview or similar). Highly proficient in Information Technology systems, including Microsoft Office suite. Proven record of working inside a team with different colleagues in any position, including being in the Lead. Being able to tailor feedback on compliance to different levels in the organization from Assistant roles to executive VP levels and in between. Knowledge of statistical methods and being able to apply that to detect outliers in data sets and/or to create thresholds such as Quality Tolerance Limits (QTLs) as required by ICH E6 (GCP) is a strong preference. Strong preference for candidates with a Project Management certificate and/or proven experience in project management for R&D related projects. Strong analytic skills for large quantities of compliance, risk management and clinical data. Strong interest in Pharmaceutical Development, mainly in the clinical research (R&D) aspects of drug development. Good-to-Have: Veeva Vault admin certification is required Experience with Veeva RIM Connectors is preferred Regulatory Information Management: Manage the lifecycle of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM. Ensure that regulatory submissions comply with applicable local and international regulations and guidelines. Maintain and update regulatory documentation, including registration dossiers, variation applications, and compliance documents. System Configuration and Maintenance: Configure and customize Veeva Vault RIM to meet organizational needs, ensuring it aligns with regulatory requirements and workflows. Monitor system performance, troubleshoot issues, and coordinate with Veeva support for resolution. Data Management: Ensure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones. Implement data governance practices to maintain compliance and quality of regulatory data. Cross-Functional Collaboration: Collaborate with various teams, including Regulatory Affairs, Quality Assurance, Clinical Development, and Pharmacovigilance, to ensure timely and accurate regulatory submissions. Act as a point of contact for regulatory queries and provide training to internal teams on Veeva RIM functionalities. Regulatory Compliance: Stay updated on regulatory changes and ensure that the organization’s processes and systems comply with current regulations and industry best practices. Participate in audits and inspections as necessary, providing documentation and system access as required. Responsibility of / Expectations from the Role : Should able to manage Regulatory information management VEEVA RIM & eTMF Demonstrated practical working experience in both processes (eg.xEVMPD) and untilisation of regulatory systems (RIMS, VEEVA) Handle Regulatory Affairs business processes Regulatory Information management VEEVA Vault RIM Align with Support Team on current issues and initiate problem management. Prepare and update application related documentation (Operational Instructions, User Manuals). Processes (eg.xEVMPD) and systems (eg.RIMS, VEEVA) Results-driven and pragmatic approach to work Good organizational skills, self-motivated and proactive Meticulous working style and high attitude to quality. Show more Show less

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6.0 years

0 Lacs

Hyderabad, Telangana, India

Remote

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Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Responsibilities Responsibilities will include, but are not limited to Study Startup Draft EDC build timeline in collaboration with Data Management Lead. Perform DB build tasks by creating specifications for Database and Edit Checks. Create test scripts and complete test data entry/UAT for Coding, Site Payment, Safety Gateway. Collaborate with Data Management Lead and facilitate startup meetings which includes, not limited to, EDC build kick-off, Interactive eCRF Build and IRMs (Interactive Review Meeting) for database and Edit checks. Create and finalize study documents like Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP) post study team review. Ensure all startup documents are completed as per SOP and filled in eTMF as per eTMF master plan. Study Conduct Plan/execute Post Production/Migration for the study (if any). Coordinate with Clinical Data Managers for the execution of data review tasks. Coordidate with external data vendors for any escalations related to any vendor data. Support Clean Patient Group delivery along with Clinical Data Management staff. Update study documents as needed during the conduct of the study Support DML to coduct Data Quality Review meetings. Provide Data Health Metrics to Data Management Lead as requested. Study Closeout- Support Data Management Lead in planning and execution of database lock activities. Perform post lock activities, as needed. Project Management Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality. Documentation Filing of appropriate documents in eTMF as per eTMF master plan. Training and Mentorship Provide Training and mentoring to junior CDM staff. Bachelor's Degree required. Life sciences, Pharmacy or relevant fields preferred. 6 years of experience in managing end to end Clinical Data Management tasks. Able to work on end to end Clinical Data Management tasks Able to work collaboratively on multi-disciplinary project teams. Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills. Strong oral and written communication skills. Strong project management skills Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Show more Show less

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6.0 years

0 Lacs

Hyderabad, Telangana, India

Remote

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Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us . Associate Manager, Clinical Data Management Responsibilities Responsibilities will include, but are not limited to Study Startup Draft EDC build timeline in collaboration with Data Management Lead. Perform DB build tasks by creating specifications for Database and Edit Checks. Create test scripts and complete test data entry/UAT for Coding, Site Payment, Safety Gateway. Collaborate with Data Management Lead and facilitate startup meetings which includes, not limited to, EDC build kick-off, Interactive eCRF Build and IRMs (Interactive Review Meeting) for database and Edit checks. Create and finalize study documents like Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP) post study team review. Ensure all startup documents are completed as per SOP and filled in eTMF as per eTMF master plan. Study Conduct Plan/execute Post Production/Migration for the study (if any). Coordinate with Clinical Data Managers for the execution of data review tasks. Coordidate with external data vendors for any escalations related to any vendor data. Support Clean Patient Group delivery along with Clinical Data Management staff. Update study documents as needed during the conduct of the study Support DML to coduct Data Quality Review meetings. Provide Data Health Metrics to Data Management Lead as requested. Study Closeout- Support Data Management Lead in planning and execution of database lock activities. Perform post lock activities, as needed. Project Management Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality. Documentation Filing of appropriate documents in eTMF as per eTMF master plan. Training and Mentorship Provide Training and mentoring to junior CDM staff. Bachelor's Degree required. Life sciences, Pharmacy or relevant fields preferred. 6 years of experience in managing end to end Clinical Data Management tasks. Able to work on end to end Clinical Data Management tasks Able to work collaboratively on multi-disciplinary project teams. Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills. Strong oral and written communication skills. Strong project management skills Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Show more Show less

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6.0 years

4 - 8 Lacs

Hyderābād

Remote

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Associate Manager, Clinical Data Management Responsibilities will include, but are not limited to: Study Startup: Draft EDC build timeline in collaboration with Data Management Lead. Perform DB build tasks by creating specifications for Database and Edit Checks. Create test scripts and complete test data entry/UAT for Coding, Site Payment, Safety Gateway. Collaborate with Data Management Lead and facilitate startup meetings which includes, not limited to, EDC build kick-off, Interactive eCRF Build and IRMs (Interactive Review Meeting) for database and Edit checks. Create and finalize study documents like Data Quality Management Plan, eCRF completion Instructions, Protocol Data Review Plan (PDRP) post study team review. Ensure all startup documents are completed as per SOP and filled in eTMF as per eTMF master plan. Study Conduct: Plan/execute Post Production/Migration for the study (if any). Coordinate with Clinical Data Managers for the execution of data review tasks. Coordidate with external data vendors for any escalations related to any vendor data. Support Clean Patient Group delivery along with Clinical Data Management staff. Update study documents as needed during the conduct of the study Support DML to coduct Data Quality Review meetings. Provide Data Health Metrics to Data Management Lead as requested. Study Closeout- Support Data Management Lead in planning and execution of database lock activities. Perform post lock activities, as needed. Project Management Support DML in project management tasks to make sure that study is delivered successfully as per the study timelines with quality. Documentation: Filing of appropriate documents in eTMF as per eTMF master plan. Training and Mentorship: Provide Training and mentoring to junior CDM staff. Bachelor's Degree required. Life sciences, Pharmacy or relevant fields preferred. 6 years of experience in managing end to end Clinical Data Management tasks. Able to work on end to end Clinical Data Management tasks Able to work collaboratively on multi-disciplinary project teams. Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills. Strong oral and written communication skills. Strong project management skills Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

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Description At Quanticate, we're pioneers in providing top-tier statistical and data management support to our clients. We're seeking a dedicated "Clinical Data Manager I" who's committed to upholding the highest standards, following procedures, and ensuring compliance with regulations, all while providing exceptional customer care. As a "Clinical Data Manager I" you will lead, co-ordinate, and action all tasks relating to Clinical Data Management from the start to the finish of a study & to project manage studies across CDM functions. Core Accountabilities Activities required of a Clinical Data Manager I (however not restricted to) are as below: To contribute to the efficient running of the CDM department as part of the CDM leadership team. Ensure launch, delivery, and completion of all CDM procedures according to contractual agreement and relevant SOPs, guidelines, and regulations To pro-actively keep abreast of current clinical data management developments and systems To assist in the creation and review of in-house SOPs. To research and provide input into in-house strategies and systems. To perform medical coding activities on projects, if assigned. To perform other reasonable tasks as requested by management. Ensure consistency of process and quality across projects. Project Management For Allocated Projects To help plan and manage study timelines and resources. To manage progress against schedules and report to management. To perform project management across all functions for a study as appropriate. Management of CRFs and all related tasks Management Of Allocated Staff Allocation of projects in conjunction with Project Management, as appropriate Performance reviews, as required. Administer training and development of staff, as required. Key Relationships Act as the primary CDM contact, both external and internal, for Quanticate projects. Manage work assignment and delivery of project tasks to the data processing and programming team as required Line management responsibilities for any assigned direct reports, including professional development/training and performance appraisals. Requirements Qualified to an appropriate standard, preferably to degree level in a life sciences subject Four to seven years of relevant experience in CRO Clinical Data Management domain. Extensive knowledge of at least 2 Clinical Data Management systems such as Oracle Clinical, Medidata Rave, Inform Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing CDM project leadership, strong communication skills Sound knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials Proven ability in client relationship management Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance. Benefits ◼ Competitive salary (Open to discussion based on experience ◼ Flexible working hours ◼ Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays) ◼ Medical Insurance for self and immediate family ◼ Gratuity ◼ Accidental Coverage ◼ Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing) Show more Show less

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3.0 years

0 Lacs

Pune/Pimpri-Chinchwad Area

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Software Engineering Consultant C# We are looking for a skilled Software Engineering Consultant (Study Transfer Developer) to join our Medidata Service team and contribute to the critical Transfer Project. In this role, you will work closely with team members in Pune, India, as well as colleagues in the United States, ensuring seamless collaboration. The Study Transfer Project involves transferring specific client data securely from one client to another, a process that demands careful handling of sensitive information and precision across each transfer step. This position is based in Pune, India. Role Description & Responsibilities Analyze, design, code, test, and debug software solutions to meet business requirements independently. Manage interdependencies between multiple systems to ensure seamless integrations. Gain a deep understanding of Medidata's product architecture and the interoperability between various Medidata products. Proactively monitor software and infrastructure changes, addressing potential impacts on deliverables. Conduct code reviews and collaborate with off-site development teams to align on best practices. Manage and track assigned tasks, ensuring timely completion and escalating issues as needed. Provide regular updates on project/task status to internal clients and leadership. Identify, document, and resolve defects uncovered during testing. Balance multiple projects, adapting to shifting priorities while maintaining quality standards. Mentor junior developers, providing technical leadership and guidance. Stay updated on Medidata products, features, and ensure compliance with relevant SOPs and work instructions. Collaborate across teams to ensure alignment with business objectives. Complete documentation for installation, maintenance, and other project deliverables. Qualifications Bachelor’s degree and a minimum of 3 years to 5 years of related experience, which can be in the form of internships, externships, baccalaureate projects; or an advanced degree without experience; or equivalent work experience. Strong in relational databases (MS SQL SQL, mySQL, and PostgreSQL) programming language Strong in Python programming language, Experience in C# and Object-Oriented programming. Proficient with MS Office product suite (Word, Excel, PowerPoint), Google product suite (Docs, Sheets, and Slides) and AWS Experience with React and utilizing REST APIs Excellent verbal/written communication and organizational skills with experience of working with off-site development teams and multidisciplinary teams. Ability to document requirements and specifications. Strong problem-solving skills and attention to detail. What’s in it for you: You’ll be part of a crucial project that directly contributes to client satisfaction by ensuring secure and accurate data transfers. Your proactive monitoring, cross-functional collaboration, and attention to detail in managing interdependencies will be valued and recognized as essential contributions to the team’s success. Working on multiple projects with shifting priorities provides a dynamic environment that keeps you engaged and allows you to develop robust problem-solving and time-management skills. You will work in collaborative culture where innovative ideas and best practices are shared. With responsibilities like mentoring junior developers and collaborating on code reviews, you’ll have ample opportunity to expand your leadership skills, technical expertise, and professional network. Inclusion statement As a game-changer in sustainable technology and innovation, Dassault Systèmes is striving to build more inclusive and diverse teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, it’s our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future. Show more Show less

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3.0 years

0 Lacs

Pune/Pimpri-Chinchwad Area

On-site

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We are looking for a skilled Software Engineering Consultant (Study Transfer Developer) to join our Medidata Service team and contribute to the critical Transfer Project. In this role, you will work closely with team members in Pune, India, as well as colleagues in the United States, ensuring seamless collaboration. The Study Transfer Project involves transferring specific client data securely from one client to another, a process that demands careful handling of sensitive information and precision across each transfer step. This position is based in Pune, India. Role Description & Responsibilities Analyze, design, code, test, and debug software solutions to meet business requirements independently. Manage interdependencies between multiple systems to ensure seamless integrations. Gain a deep understanding of Medidata's product architecture and the interoperability between various Medidata products. Proactively monitor software and infrastructure changes, addressing potential impacts on deliverables. Conduct code reviews and collaborate with off-site development teams to align on best practices. Manage and track assigned tasks, ensuring timely completion and escalating issues as needed. Provide regular updates on project/task status to internal clients and leadership. Identify, document, and resolve defects uncovered during testing. Balance multiple projects, adapting to shifting priorities while maintaining quality standards. Mentor junior developers, providing technical leadership and guidance. Stay updated on Medidata products, features, and ensure compliance with relevant SOPs and work instructions. Collaborate across teams to ensure alignment with business objectives. Complete documentation for installation, maintenance, and other project deliverables. Bachelor’s degree and a minimum of 3 years to 5 years of related experience, which can be in the form of internships, externships, baccalaureate projects; or an advanced degree without experience; or equivalent work experience. Strong in relational databases (MS SQL SQL, mySQL, and PostgreSQL) programming language Strong in Python programming language, Experience in C# and Object-Oriented programming. Proficient with MS Office product suite (Word, Excel, PowerPoint), Google product suite (Docs, Sheets, and Slides) and AWS Experience with React and utilizing REST APIs Excellent verbal/written communication and organizational skills with experience of working with off-site development teams and multidisciplinary teams. Ability to document requirements and specifications. Strong problem-solving skills and attention to detail. What’s in it for you: You’ll be part of a crucial project that directly contributes to client satisfaction by ensuring secure and accurate data transfers. Your proactive monitoring, cross-functional collaboration, and attention to detail in managing interdependencies will be valued and recognized as essential contributions to the team’s success. Working on multiple projects with shifting priorities provides a dynamic environment that keeps you engaged and allows you to develop robust problem-solving and time-management skills. You will work in collaborative culture where innovative ideas and best practices are shared. With responsibilities like mentoring junior developers and collaborating on code reviews, you’ll have ample opportunity to expand your leadership skills, technical expertise, and professional network. Inclusion statement As a game-changer in sustainable technology and innovation, Dassault Systèmes is striving to build more inclusive and diverse teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, it’s our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future. Show more Show less

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0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

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At Quanticate, we're pioneers in providing top-tier statistical and data management support to our clients. We're seeking a dedicated "Clinical Data Manager I" who's committed to upholding the highest standards, following procedures, and ensuring compliance with regulations, all while providing exceptional customer care. As a "Clinical Data Manager I" you will lead, co-ordinate, and action all tasks relating to Clinical Data Management from the start to the finish of a study & to project manage studies across CDM functions. Core Accountabilities: Activities required of a Clinical Data Manager I (however not restricted to) are as below: To contribute to the efficient running of the CDM department as part of the CDM leadership team Ensure launch, delivery, and completion of all CDM procedures according to contractual agreement and relevant SOPs, guidelines, and regulations To pro-actively keep abreast of current clinical data management developments and systems To assist in the creation and review of in-house SOPs. To research and provide input into in-house strategies and systems. To perform medical coding activities on projects, if assigned. To perform other reasonable tasks as requested by management. Ensure consistency of process and quality across projects. Project management for allocated projects: To help plan and manage study timelines and resources. To manage progress against schedules and report to management. To perform project management across all functions for a study as appropriate. Management of CRFs and all related tasks Management of allocated staff: Allocation of projects in conjunction with Project Management, as appropriate Performance reviews, as required. Administer training and development of staff, as required Key Relationships: Act as the primary CDM contact, both external and internal, for Quanticate projects Manage work assignment and delivery of project tasks to the data processing and programming team as required Line management responsibilities for any assigned direct reports, including professional development/training and performance appraisals Requirements Qualified to an appropriate standard, preferably to degree level in a life sciences subject Four to seven years of relevant experience in CRO Clinical Data Management domain Extensive knowledge of at least 2 Clinical Data Management systems such as Oracle Clinical, Medidata Rave, Inform Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing CDM project leadership, strong communication skills Sound knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials Proven ability in client relationship management Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance. Benefits ◼ Competitive salary (Open to discussion based on experience ◼ Flexible working hours ◼ Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays) ◼ Medical Insurance for self and immediate family ◼ Gratuity ◼ Accidental Coverage ◼ Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing) Show more Show less

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3.0 - 5.0 years

0 Lacs

India

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Premier Research is looking for a Data Management Reporting Programmer (SQL Developer) - Fixed Term Contract - India to join our Functional Services Provider (FSP) team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech™. Join us and build your future here. What You Will Be Doing Works with cross-functional study team members in a programming capacity to create reporting solutions that support the quality and timely delivery of data management reports and visualizations required per standard and study specific data review plans Creates, enhances, and decommissions data management reports in accordance with applicable standard operating procedures Ensures timelines and milestones are met in collaboration with cross functional teams Creates any needed documentation for reports and ensures proper filing Works across the portfolio to increase automated reporting (e.g. - JReview, Spotfire) and review in order to streamline effort on data intensive studies Enhances available reporting tools or creates new ones to support the review of clinical trial data and trial status information for cross-functional use Provides input on data management reporting standards as required What We Are Searching For Bachelor’s degree, or international equivalent from an accredited institution, preferably in a programming, technical, clinical, or health-related field, or equivalent combination of education, training and experience 3 to 5 years of practical experience using commercial clinical data management systems (eg – Oracle RDC / Inform, Medidata Rave, Datalabs, etc) or data visualization reporting tools (e.g. Spotfire, jReview). Alternatively, must have proven experience in all primary job functions Practical experience with SQL or similar programming language required Demonstrates excellent English verbal and written communication skills Excellent computer skills in a Microsoft Windows environment including proficiency in the Microsoft Office Suite of tools (eg - Outlook, Work, Excel, etc) Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities Show more Show less

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0 years

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India

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Company Description ClinFocus empowers life sciences organizations to accelerate clinical trials through technology-driven solutions. Our services include EDC Development, Systems Integration, AI Deployment & Enablement, Clinical Data Science, Project Management, and Development of Integrated Dashboards. As an ISO-certified organization and partner of Medidata Rave, we are committed to excellence and trust in clinical research. We are seeking a highly motivated and skilled Clinical Statistical Programmer to join our dynamic Biometrics team. In this role, you will be instrumental in the development, validation, and maintenance of programs used for the analysis and reporting of clinical trial data. You will work closely with biostatisticians, data managers, and clinical scientists to ensure the accurate and timely delivery of high-quality statistical outputs. Responsibilities: Develop, validate, and maintain SAS programs for the creation of SDTM and ADaM datasets, tables, listings, and figures (TLFs) according to statistical analysis plans (SAPs) and programming specifications. Ability to contribute to the development and implementation of Statistical Analyses Plan Perform quality control (QC) of programs and outputs generated by other statistical programmers to ensure accuracy, consistency, and adherence to company standards and regulatory guidelines. Collaborate with biostatisticians to clarify programming requirements, resolve data issues, and ensure the accurate implementation of statistical methodologies. Contribute to the development and review of programming specifications, mock TLFs, and other study-related documentation. Ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH-GCP) and internal Standard Operating Procedures (SOPs). Participate in team meetings and contribute to discussions regarding study design, data analysis, and reporting strategies. Proactively identify and implement process improvements to enhance efficiency and quality of programming deliverables. Maintain comprehensive documentation of programming activities and version control. May contribute to the development and maintenance of programming standards and macros. Qualifications: Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related scientific field. Minimum of3] years of experience in clinical statistical programming within the pharmaceutical, biotechnology, or CRO industry. Proficiency in SAS programming (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macro Language). Strong understanding of CDISC standards, including SDTM and ADaM. Experience with regulatory submissions (e.g., NDA, BLA) is highly desirable. Solid understanding of clinical trial processes, ICH-GCP guidelines, and relevant regulatory requirements. Excellent attention to detail and strong problem-solving skills. Ability to work independently and as part of a collaborative team. Strong written and verbal communication skills. Experience with other programming languages (e.g., R, Python) is a plus. Knowledge of industry best practices for statistical programming. What We Offer: Opportunity to work on innovative clinical trials across diverse therapeutic areas. A collaborative and supportive work environment. Opportunities for professional growth and development. Competitive salary and benefits package. Show more Show less

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3.0 years

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India

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Company Description ClinFocus is a life sciences organization that specializes in accelerating clinical trials and enhancing data quality through technology-driven solutions. Our services include EDC Development, Systems Integration, AI Deployment & Enablement, Clinical Data Science, Project Management, and Development of Integrated Dashboards. We are an ISO-certified organization and an accredited partner of Medidata Rave, dedicated to delivering excellence and building trust. ClinFocus is seeking an experienced and highly detail-oriented Quality Assurance Manager to lead and enhance our quality management system across all clinical data management and technology services. This critical role will ensure that all processes, deliverables, and systems adhere to regulatory requirements (e.g., FDA, EMA, ICH-GCP), industry best practices, and internal Standard Operating Procedures (SOPs). The Quality Assurance Manager will be instrumental in fostering a culture of quality and continuous improvement throughout the organization. Responsibilities: Develop, implement, and maintain ClinFocus's Quality Management System (QMS) in accordance with applicable regulatory guidelines (e.g., 21 CFR Part 11, ICH-GCP, GAMP 5). Oversee and conduct internal and external audits to ensure compliance with QMS, SOPs, client requirements, and regulatory standards. Manage and lead all quality assurance activities related to clinical data management, EDC system development, data analytics, and other technology solutions. Develop and manage the CAPA (Corrective and Preventive Action) program, ensuring timely investigation, resolution, and effectiveness checks of identified quality issues. Serve as the primary point of contact for client audits and regulatory inspections, facilitating responses and managing follow-up actions. Provide expert guidance and training to staff on quality assurance principles, regulatory requirements, and internal procedures. Review and approve key study documents, including Data Management Plans, Validation Plans, UAT documentation, and programming specifications, from a quality perspective. Participate in vendor qualification and oversight activities, ensuring that third-party services meet ClinFocus's quality standards. Identify opportunities for process improvements and work collaboratively with cross-functional teams to implement efficiencies while maintaining quality. Maintain comprehensive quality metrics and prepare regular reports for management on QMS performance and compliance status. Stay current with evolving regulatory requirements and industry trends in clinical research and data management. Qualifications: Bachelor's or Master's degree in a life science, computer science, or a related field. Minimum of 3 years of progressive experience in Quality Assurance within the pharmaceutical, biotechnology, CRO, or medical device industry In-depth knowledge of global regulatory requirements and industry standards for clinical trials, including ICH-GCP, 21 CFR Part 11, and relevant Annexes to EU GMP. Proven experience in developing, implementing, and managing a QMS. Strong understanding of clinical data management processes, EDC systems (e.g., Medidata Rave), and data integrity principles. Experience with audit management (internal, external, and regulatory inspections). Demonstrated experience with CAPA management. Excellent analytical, problem-solving, and decision-making skills. Exceptional written and verbal communication skills, with the ability to articulate complex quality concepts clearly and concisely. Strong interpersonal skills and the ability to build effective working relationships with internal teams and external clients. Certifications in Quality Assurance (e.g., ASQ Certified Quality Auditor, RAPS Regulatory Affairs Certification) are a plus. Experience with GAMP 5 principles for computerized system validation is highly desirable. What We Offer: The opportunity to play a pivotal role in ensuring the quality and compliance of innovative clinical trial solutions. A collaborative and supportive environment where your expertise is valued. Opportunities for professional growth and leadership development. Competitive compensation and benefits package. Show more Show less

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0 years

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Hyderabad, Telangana, India

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Jd Cdm 3.5 + yrs of minimum Clinical Data Management experience Must have exposure to Study Start up, Conduct and Study Closeout. If not three phases should have good exposure to minimum two phases. Rave (Medidata) or Veeva EDC hands on experience is must. Must Have Setup experience should have knowledge of DMP (Data Management Plan) creation, Edit check creation, Data Transfer specification creation, UAT knowledge (not mandatory). Conduct Experience Data Cleaning experience (Query Handling), Postproduction Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc . Study Lock Freezing/Locking, should have good experience of Study lock Client facing role and Mentoring are added advantage. 1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities. 2 Participate in innovation and process improvement initiatives. 3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs. 4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information. 5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required. 6 Study Setup hands on experience. 7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool , 8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication Show more Show less

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6.0 years

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Andhra Pradesh

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Key Responsibilities: Understand and document business and data requirements across clinical domains and translate them into actionable technical tasks Manage and maintain Jira boards for the Data Engineering team: groom stories, track progress, and coordinate with developers, QA, and stakeholders Act as a liaison between product, engineering, and external stakeholders to clarify requirements and ensure alignment across teams Drive the creation and maintenance of data entity mapping documentation between legacy systems and Medidata CTMS Collaborate with engineering leads to support ETL and data pipeline validation, including defining edge cases and expected behaviors Support UAT efforts for data integration/migration projects by coordinating validation cycles with clinical users and data stakeholders Identify risks, gaps, or inconsistencies in incoming data requirements and proactively resolve them Participate in data migration planning and execution experience with previous system-to-system migrations is a strong plus Required Qualifications: Minimum of 6 years of experience as a Business Analyst or Technical BA in the clinical trials or life sciences domain Strong understanding of clinical data and clinical workflows Experience with Jira, Confluence, and Agile/Scrum delivery models Familiarity with data models, data structures, and relational data concepts (SQL knowledge is a plus) Strong written and verbal communication skills with the ability to simplify complex topics for non-technical stakeholders Ability to manage multiple workstreams and keep deliverables on track Proven ability to create clear, structured documentation (e.g., data dictionaries, mappings, process flows) Preferred Qualifications: Experience with clinical data migrations (e.g from Veeva, Oracle, or other CTMS systems to other systems) Understanding of ETL pipelines or working experience with data engineering teams Knowledge of CTMS, eTMF, EDC/Rave, or other clinical trial technologies About Virtusa Teamwork, quality of life, professional and personal development: values that Virtusa is proud to embody. When you join us, you join a team of 27,000 people globally that cares about your growth — one that seeks to provide you with exciting projects, opportunities and work with state of the art technologies throughout your career with us. Great minds, great potential: it all comes together at Virtusa. We value collaboration and the team environment of our company, and seek to provide great minds with a dynamic place to nurture new ideas and foster excellence. Virtusa was founded on principles of equal opportunity for all, and so does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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2.0 years

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Bengaluru, Karnataka, India

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Clinical Database Programmers are operationally responsible to provide technical support and oversight for the Medidata Clinical Cloud (MCC) implementation activities. Clinical Database Programmers will maintain project level perspective, focus and communicate effectively as the MCC SME on technical and functional electronic data capture programming and data management activities, timelines and deliverables. Key Tasks & Responsibilities Design/develop and test clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, standard and custom reports Performs peer review for the studies built by other Clinical Database Programmers Responsible for the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules Manages timely-quality deliverables for the study teams for assigned protocol/study(s) Functions as an EDC Subject Matter Expert (SME) providing guidance and best practice recommendations to Data Management, operations teams, and other stakeholders on basic Medidata Rave functionality Working knowledge of additional Medidata Rave modules, including Coder, RTSM, Lab Admin, iMedidata/Cloud Admin or other modules. Other duties as assigned CANDIDATE’S PROFILE Education & Experience Bachelor’s degree or equivalent work experience preferred 2+ years in Pharmaceutical/Biotechnology industry or equivalent preferred Experience with requirements gathering, design and specification development of CRFs, edit checks, site queries, and understanding of database structures and programming languages Professional Skills Ability to work creatively and independently to carry out assignments of a complex nature Ability to communicate and work effectively and cooperatively with other professional staff members Detail oriented, ability to multitask with strong prioritization, planning and organization skills Excellent knowledge of English; verbal and written communication skills Technical Skills Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology preferred Programming Languages: C# Expert knowledge of Medidata Clinical Cloud (MCC) especially Rave EDC capabilities and best practices Familiarity with Clinical Systems and technologies: ePRO, IVRS/IWRS, CTMS Experience with Data Reporting Tools: Business Objects, JReview, Cognos, Crystal Reports or related preferred Show more Show less

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3.0 years

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Bengaluru, Karnataka, India

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Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects. You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Clinical Database Developers: Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred. Extensive experience in database design, edit check programming, custom function programming and unit testing. Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred. Show more Show less

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0 years

7 - 10 Lacs

Bengaluru

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Job Title: Associate Director, GCS Business Technology Solutions Introduction to role: Are you ready to make a significant impact in the world of Biopharma Clinical Operations? As an Associate Director in GCS Business Technology Solutions, you'll be at the forefront of driving industry-leading processes, technology, and services. Your role will be pivotal in owning the lifecycle management and continuous improvement of specific clinical operations processes, systems, or services. Collaborate with internal and external stakeholders to ensure customer needs are met and optimize the delivery of clinical studies. You'll identify and deliver improvements using tools like Lean Six Sigma to improve clinical study delivery. Are you up for the challenge? Accountabilities: Design, develop, implement, maintain, continuously improve, and provide ongoing customer support. Manage lifecycle of all system documents ensuring compliance with industry regulations and AstraZeneca policies. Communicate effectively and timely, providing high-quality training materials. Provide training, advice, and end-user support. Engage and influence key partners to drive strategy, development, and continuous improvement. Understand, evaluate, prioritize, and address customer requirements. Supervise performance by defining, tracking, and using key performance indicators for process improvements. Support audit and regulatory inspection planning, preparation, and conduct. Promote creative and innovative ideas to drive performance and deliver new solutions to customers. Essential Skills/Experience: Bachelor’s of Science in an appropriate subject area or equivalent experience Extensive knowledge of Drug Development within a pharmaceutical or clinical background High level of business process, technology and Clinical Study information experience Demonstrated project management skills to deliver to time, cost and quality Ability to collaborate with, motivate and empower others to accomplish objectives Experience working successfully with external partners delivering mutual benefit Excellent written, verbal, influencing skills; negotiation, teamwork, problem solving, presentation skills Experience in Medidata Rave including iMedidata user and site administration Desirable Skills/Experience: Expert reputation within the business and industry Experience using standard process improvement methodologies (e.g. Lean Six Sigma) Experience in development and management of Business Processes for performance delivery Comprehensive knowledge of ICH/GCP Extensive experience in Validation of computerised systems in a regulated environment Extensive experience of Quality Systems and Quality Management Medidata Study Builder certification Experience in other EDC systems (e.g Veeva, Bioclinica) Experience in other Medidata products including Rave EDC When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, you'll find yourself in an environment that values transparency and expertise. Here, you can apply your skills across various functions to make decisions that prioritize patients. With a focus on continuous improvement and innovation, you'll be supported by leaders who empower you to work on initiatives that benefit both you and the business. Embrace global opportunities as you supply to research that makes a tangible difference worldwide. Ready to take on this exciting role? Apply now and become part of our diverse team!

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0.0 - 45.0 years

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Bengaluru, Karnataka

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Job ID R-228515 Date posted 06/09/2025 Job Title: Associate Director, GCS Business Technology Solutions Introduction to role: Are you ready to make a significant impact in the world of Biopharma Clinical Operations? As an Associate Director in GCS Business Technology Solutions, you'll be at the forefront of driving industry-leading processes, technology, and services. Your role will be pivotal in owning the lifecycle management and continuous improvement of specific clinical operations processes, systems, or services. Collaborate with internal and external stakeholders to ensure customer needs are met and optimize the delivery of clinical studies. You'll identify and deliver improvements using tools like Lean Six Sigma to improve clinical study delivery. Are you up for the challenge? Accountabilities: Design, develop, implement, maintain, continuously improve, and provide ongoing customer support. Manage lifecycle of all system documents ensuring compliance with industry regulations and AstraZeneca policies. Communicate effectively and timely, providing high-quality training materials. Provide training, advice, and end-user support. Engage and influence key partners to drive strategy, development, and continuous improvement. Understand, evaluate, prioritize, and address customer requirements. Supervise performance by defining, tracking, and using key performance indicators for process improvements. Support audit and regulatory inspection planning, preparation, and conduct. Promote creative and innovative ideas to drive performance and deliver new solutions to customers. Essential Skills/Experience: Bachelor’s of Science in an appropriate subject area or equivalent experience Extensive knowledge of Drug Development within a pharmaceutical or clinical background High level of business process, technology and Clinical Study information experience Demonstrated project management skills to deliver to time, cost and quality Ability to collaborate with, motivate and empower others to accomplish objectives Experience working successfully with external partners delivering mutual benefit Excellent written, verbal, influencing skills; negotiation, teamwork, problem solving, presentation skills Experience in Medidata Rave including iMedidata user and site administration Desirable Skills/Experience: Expert reputation within the business and industry Experience using standard process improvement methodologies (e.g. Lean Six Sigma) Experience in development and management of Business Processes for performance delivery Comprehensive knowledge of ICH/GCP Extensive experience in Validation of computerised systems in a regulated environment Extensive experience of Quality Systems and Quality Management Medidata Study Builder certification Experience in other EDC systems (e.g Veeva, Bioclinica) Experience in other Medidata products including Rave EDC When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, you'll find yourself in an environment that values transparency and expertise. Here, you can apply your skills across various functions to make decisions that prioritize patients. With a focus on continuous improvement and innovation, you'll be supported by leaders who empower you to work on initiatives that benefit both you and the business. Embrace global opportunities as you supply to research that makes a tangible difference worldwide. Ready to take on this exciting role? Apply now and become part of our diverse team! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Associate Director, GCS Business Technology Solutions Posted date Jun. 09, 2025 Contract type Full time Job ID R-228515 APPLY NOW Why choose AstraZeneca India? Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare. The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports. Who do we look for? Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day. Success Profile Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for. 0% Tech innovators Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives. 0% Ownership takers If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it. 0% Challenge seekers Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks. 0% Proactive collaborators Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best. Responsibilities Job ID R-228515 Date posted 06/09/2025 Job Title: Associate Director, GCS Business Technology Solutions Introduction to role: Are you ready to make a significant impact in the world of Biopharma Clinical Operations? As an Associate Director in GCS Business Technology Solutions, you'll be at the forefront of driving industry-leading processes, technology, and services. Your role will be pivotal in owning the lifecycle management and continuous improvement of specific clinical operations processes, systems, or services. Collaborate with internal and external stakeholders to ensure customer needs are met and optimize the delivery of clinical studies. You'll identify and deliver improvements using tools like Lean Six Sigma to improve clinical study delivery. Are you up for the challenge? Accountabilities: Design, develop, implement, maintain, continuously improve, and provide ongoing customer support. Manage lifecycle of all system documents ensuring compliance with industry regulations and AstraZeneca policies. Communicate effectively and timely, providing high-quality training materials. Provide training, advice, and end-user support. Engage and influence key partners to drive strategy, development, and continuous improvement. Understand, evaluate, prioritize, and address customer requirements. Supervise performance by defining, tracking, and using key performance indicators for process improvements. Support audit and regulatory inspection planning, preparation, and conduct. Promote creative and innovative ideas to drive performance and deliver new solutions to customers. Essential Skills/Experience: Bachelor’s of Science in an appropriate subject area or equivalent experience Extensive knowledge of Drug Development within a pharmaceutical or clinical background High level of business process, technology and Clinical Study information experience Demonstrated project management skills to deliver to time, cost and quality Ability to collaborate with, motivate and empower others to accomplish objectives Experience working successfully with external partners delivering mutual benefit Excellent written, verbal, influencing skills; negotiation, teamwork, problem solving, presentation skills Experience in Medidata Rave including iMedidata user and site administration Desirable Skills/Experience: Expert reputation within the business and industry Experience using standard process improvement methodologies (e.g. Lean Six Sigma) Experience in development and management of Business Processes for performance delivery Comprehensive knowledge of ICH/GCP Extensive experience in Validation of computerised systems in a regulated environment Extensive experience of Quality Systems and Quality Management Medidata Study Builder certification Experience in other EDC systems (e.g Veeva, Bioclinica) Experience in other Medidata products including Rave EDC When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. At AstraZeneca, you'll find yourself in an environment that values transparency and expertise. Here, you can apply your skills across various functions to make decisions that prioritize patients. With a focus on continuous improvement and innovation, you'll be supported by leaders who empower you to work on initiatives that benefit both you and the business. Embrace global opportunities as you supply to research that makes a tangible difference worldwide. Ready to take on this exciting role? Apply now and become part of our diverse team! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. APPLY NOW Explore the local area Take a look at the map to see what’s nearby. Reasons to Join Thomas Mathisen Sales Representative Oslo, Norway Christine Recchio Sales Representative California, United States Stephanie Ling Sales Representative Petaling Jaya, Malaysia What we offer We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you. Lifelong learning Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still. Autonomy and reward Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package. Health and wellbeing An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority. Inclusion and diversity Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.

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6.0 years

0 Lacs

Chennai, Tamil Nadu, India

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Job Summary: We are seeking a Medidata eTMF/CTMS Product Consultant to support the implementation and use of Medidata eTMF/CTMS Key Responsibilities Implement and support Medidata eTMF/CTMS Perform configuration changes. Oversee master data creation and study setup. Manage user access, roles, and permissions. Perform data reconciliation and cleanup. Generate report dashboards in Visual Analytics. Troubleshoot user issues and submit enhancements. Ensure compliance with regulatory standards. Conduct user training sessions. Collaborate with cross-functional teams. Generate user training manuals. Qualifications Bachelor's degree in Life Sciences, IT, or related field. 6+ years of relevant IT experience. Experience with Medidata eTMF/CTMS Understanding of clinical trial processes. Strong problem-solving and communication skills. Show more Show less

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5.0 years

0 Lacs

India

Remote

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Company Description ClinFocus is a leading provider of technology-driven solutions and expert services for life sciences organizations to accelerate their clinical trials and gain deeper insights. Our services include EDC development, systems integration, AI deployment & enablement, clinical data science, project management, and development of integrated dashboards. As an ISO-certified organization and an accredited partner of Medidata Rave, ClinFocus is dedicated to delivering excellence and building trust through exceptional work ethics and ownership. Role Description This is a full-time remote role for a Clinical Systems and Data Manager. The Clinical Systems and Data Manager will be responsible for managing clinical data, ensuring data validation, overseeing electronic data capture (EDC) systems, and maintaining clinical data management processes on a day-to-day basis. Qualifications 5 years of industry experience Data Management and Clinical Data Management skills Data Validation expertise Experience with Electronic Data Capture (EDC) systems Strong understanding of Clinical Data Proficiency in data analysis and interpretation Excellent organizational and project management skills Attention to detail and problem-solving abilities Knowledge of regulatory requirements in clinical research Show more Show less

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8.0 years

0 Lacs

Andhra Pradesh, India

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Looking for experienced Full Stack engineer who is passionate about application development. Primary responsibilities will include hands-on development of Medidata's software applications with Java, Clojure, Python, R, React/Typescript, and Amazon Web Services. Responsibilities 8+ years hands on experience in Java , ready to shift gears to Clojure (a must), python as needed Working experience with AWS (cloud watch , Lambdas, Sagemaker, familiar with container orchestration ECS / EKS) . Proficient in React, including both class components and hooks Strong understanding of Redux for state management (actions, reducers, middleware) Experienced with TypeScript in large-scale front-end applications Skilled in building reusable components and managing component lifecycles Familiar with async data flows and handling side effects (e.g., redux-thunk) Comfortable with type-safe patterns and strict typing in UI logic Capable of writing unit and integration tests (Jest, React Testing Library) Knowledgeable in performance optimization and render lifecycle debugging Develop, test, document, deploy and maintain applications in a production environment. Apply good technical practices such as continuous integration, test automation, and Github Pull Request reviews. Apply your experience with enterprise design patterns and principles, and distributed system architecture to implement product features. Work with Agile team members, collaborating with testers to ensure quality and with product managers to turn great ideas into detailed requirements. Promote and ensure the high quality, performance, security of our solutions. Promote and implement DevOps, CI/CD and automation strategies. Show more Show less

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3.0 years

0 Lacs

Hyderabad, Telangana, India

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Job title : Data Validation Team Member Hiring Manager: Project Lead-ESR & Grants Location: Hyderabad % of travel expected: Travel required as per business need Job type: Permanent and Full time About The Job Our Team: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions . Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally. The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool. Main Responsibilities Sanofi is seeking a dedicated and detail-oriented Data Validation Team Member to join our team. The successful candidate will be responsible for ensuring the accuracy and quality of clinical data through comprehensive validation and quality control processes. Key Responsibilities System and Data Collection: Understand system and data collection processes, including electronic Case Report Forms (eCRFs) in the Medidata RAVE (EDC) application. Data Verification: Verify data for consistency and identify discrepancies. Query Management: Raise and manage queries to resolve data issues. User Acceptance Testing (UAT): Perform UAT for CRF changes and system updates, document findings, and assist with other tasks as needed. Issue Log Management: Update issue logs with data issues and resolutions. Metrics Creation: Create form entry and query metrics. Metrics Tracking: Track eCRF review and backlog metrics. Data Review: Review data listings produced in SAS, ad-hoc reporting, and scanned reports for accuracy. Quality Control: Ensure quality control of all activities in-scope, as discussed and required by Sanofi. Reconciliation: Perform data reconciliation to ensure data integrity. Guideline Input: Provide input to Data Review Guidelines (DRG) and Quality Management & Control Plan. Documentation: Draft project documents on an ad-hoc basis. Training Facilitation: Facilitate training for new team members and create test cases. People: (1) Seek alignment with internal stakeholders, and appropriate prioritization of Registry study data management activities, and compliance with approved processes; (2) Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business Performance: (1) Ensure that the data validation methods produce accurate and reliable results (2) Identify sources of data validity problems and implementing data-driven quality improvement processes; (3) Ensure operational excellence and compliance readiness. Process:(1) Understand system and data collection processes, including electronic Case Report Forms (eCRFs) in the Medidata RAVE (EDC) application. (2) Verify data for consistency and identify discrepancies. (3) Raise and manage queries to resolve data issues. (4) Perform UAT for CRF changes and system updates, document findings, and assist with other tasks as needed. (5) Update issue logs with data issues and resolutions. (6) Create form entry and query metrics. (7) Track eCRF review and backlog metrics. (8) Review data listings produced in SAS, ad-hoc reporting, and scanned reports for accuracy. (9) Ensure quality control of all activities in-scope, as discussed, and required by Sanofi. (10) Perform data reconciliation to ensure data integrity. (11) Provide input to Data Review Guidelines (DRG) and Quality Management & Control Plan. (12) Draft project documents on an ad-hoc basis. (13) Facilitate training for new team members and create test cases. Stakeholder: (1) Commit to Customers – Understand, meet, and excel internal and external customer expectations to create positive impact through the evolution of the Registry Data management function. (2) Cooperate Transversally – Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact Registry study data management efficiency and execution. About You Experience: 3+ years of Experience with Medidata RAVE (EDC) application and SAS. Strong attention to detail and analytical skills. Excellent communication and documentation skills. Ability to work independently and as part of a team. Previous experience in a similar role within the pharmaceutical or clinical research industry. Familiarity with regulatory requirements and guidelines for clinical data management. Soft skills: Excellent written and oral communication skills. Excellent organizational and project management skills, and ability to meet deadlines and stakeholder management. Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors. Previous experience in a similar role within the pharmaceutical or clinical research industry. Familiarity with regulatory requirements and guidelines for clinical data management. Technical skills: Proficiency in data management tools and software (e.g., SQL, SAS, R, Python) Understanding of data cleaning, transformation, and validation techniques. Familiarity with clinical data standards such as CDISC (Clinical Data Interchange Standards Consortium) and HL7 (Health Level Seven International). Knowledge of regulatory requirements and guidelines from bodies like the FDA and EMA. Education: Degree in a scientific discipline or a related Life science degree with substantial experiences with data management of clinical trials. Efficiently managing multiple tasks and deadlines. Meticulous in reviewing data to ensure accuracy and completeness. Languages: High Proficiency in written and spoken English. Pursue progress, discover extraordinary. Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! null Show more Show less

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10.0 years

0 Lacs

Vapi, Gujarat, India

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Job Title: Legal & Contract Manager – Biologics & CRO (Legal Focus) Location: Vapi, Gujarat About the Role We are seeking an experienced Contract Manager with a strong background in legal writing to support global contract management for clinical research organizations (CROs) and pharmaceutical/biologics programs. The role involves drafting, reviewing, and negotiating complex agreements within regulated environments, collaborating cross-functionally with legal, clinical, procurement, and business development teams. Key Responsibilities Draft, review, and negotiate a wide range of agreements including: Clinical Trial Agreements (CTAs) Confidentiality Disclosure Agreements (CDAs) Master Service Agreements (MSAs) Statements of Work (SOWs), Licensing, Consulting & Collaboration Agreement. Ensure compliance with internal policies and external regulations (ICH-GCP, FDA, EMA, etc.) Liaise with internal legal counsel, investigators, sponsors, and CRO partners Track contract timelines, approvals, renewals, and change orders Maintain contract templates and standard terms in line with global guidelines Mitigate legal and financial risks while safeguarding organizational interests Support audits and due diligence processes related to contracts and vendor relationships Preferred Qualifications Bachelor’s/Master’s Degree in Law, Life Sciences, Pharmacy, or related field 5–10 years of experience in contract management within CROs, biologics and biotech industry Strong understanding of clinical development phases and regulatory frameworks Exceptional legal writing, communication, and negotiation skills Proficiency with contract management systems (e.g., Medidata, Veeva Vault, or equivalent) Nice to Have Certification in Contract Law or Clinical Trial Regulations Exposure to biologics, gene therapy, or oncology-related trials Familiarity with global regulatory authorities and submission protocols Show more Show less

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5.0 years

0 Lacs

India

Remote

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As a Medical Coding Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Location: Remote Shift: 2pm-11pm IST What You Will Be Doing Coding performed in accordance with departmental coding conventions and company SOPs. The coder will generate queries for clarification of potentially discrepant data. Ability to work in cross-functional team-oriented environments. Assist with data coding consistency reviews and SAE reconciliation, as needed. The Coder will collaborate with medical monitors, Clinical and Data Management team members, as required, to ensure the timely processing of coding, according to project timelines. You Are 5+ years of experience as medical coder Experience with MedDRA and WHODD required. Experience with set-up activities Dictionary up version Medidata Rave experience ATC coding experience Working knowledge of medical terminology, clinical trials & coding is essential. What ICON Can Offer You Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our Benefits Examples Include Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Show more Show less

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0 years

4 - 8 Lacs

Bengaluru

On-site

Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5467 Position Summary: The Senior/Principal Clinical Database Manager is responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications. Position will interface directly with the internal team (i.e. Data Management, Project Management, etc.), EDC vendor, clients and third-party vendors to gather requirements and provide status updates. Provides operational and technical training to end users and junior staff. Additionally, the Senior/Principal Clinical Database Manager may play a lead role in internal software projects that require specialized programming and/or scripting. Qualifications: Minimum Required: Must have experience in developing and customizing clinical data management databases in a clinical, scientific or health care discipline Bachelor’s and/or a combination of related experience Medidata Rave EDC Certified Study Builder Rave API integration experience using external vendor modules Rave Advanced Custom Function programming experience Other Required: Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook. Able to handle a variety of clinical research tasks. Excellent organizational and communication skills Professional use of the English language; both written and oral. Experience in Object Oriented Programming (C#, C++, VBS, etc.…), scripting language (PERL, etc.), SAS, R, SQL Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.) Experience in clinical database management system development. Experience in a clinical, scientific or healthcare discipline. Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong leadership and interpersonal skills Must be able to communicate effectively in the English language. Preferred: Oncology and/or Orphan Drug therapeutic experience Base SAS®, SAS/STAT and SAS/ACCESS software SAS Macro programming language Advanced experience in Database Management, object-oriented programming Veeva set up experience It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

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2.0 years

5 - 6 Lacs

Bengaluru

On-site

Bangalore Karnataka India Job Type: Regular Full-time Division: Precision for Medicine Business Unit: Clinical Solutions Requisition Number: 5543 Job Description Position Summary The primary responsibility of the Clinical Systems Administrator is to provide business administration support for the Sponsor’s clinical systems, including but not limited to eTMF/CTMS, IRT and EDC systems (i.e., Veeva Clinical Vault and Medidata CTMS). The Clinical Systems Administrator will work with the Clinical Systems Manager/Sr. Manager and Project teams to ensure on-time deliverables and provide clinical systems user support as outlined below. Essential functions of the job include but are not limited to: Responsible for User Access management for internal, sponsor and 3rd party access requests to the Clinical Systems and other business systems. Manages the data entry into the Global Directory within Precisions Clinical System of all Sites, Institutions and update as required. Manages the creation of studies, countries and sites within the Clinical System Responsible for resolving help desk tickets assigned, either by answering questions, trouble shoot problems or identify system performance issues or deficiencies. Perform Clinical System modifications and updates to picklists, field requirements Manages the review of Clinical System processes and procedures Supports with initiating the integrations between the Clinical system and Electronic Data Capture system Performs archival steps within the Clinical System as the request was received. Support the leads or manager in any ad-hoc tasks assigned. Qualifications Minimum Required: Degree, or equivalent experience ideally in a business, scientific or healthcare discipline 2 years’ clinical trial experience with 2 years of experience with Clinical Systems Other Required: Experience in clinical trial systems (e.g., CTMS, EDC, eTMF and RTMS) with detailed understanding of requirements gathering, documentation, configuration and integrations. Preferred: Demonstrate skills in effective communication (written, oral, and presentation) to all levels including end-users, vendors, and Management Teams. Possess the ability to effectively communicate business needs to IT technology partners. Skills: Ability to resolve issues independently with good judgement to escalate appropriately. Ability to learn new systems and integration requirements. Strong interpersonal, verbal and written communication skills It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2021 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

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