652 Clinical Trials Jobs - Page 18

Should have Strong Knowledge in medical review of ICSRs and Pharmacovigilance Knowledge of safety databases, such as Argus, ARISg. Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B). Required Candidate profile Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature. BDS and MBBS Are eligible to apply

Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Processing literature, spontaneous clinical trial and solicited cases Responsible for coding events, indications and patient history based on MEDDRA Required Candidate profile EDUCATION: M.Pharm/Pharm D/Life sciences / Microbiology / Biotech /Biochem /Nursing / BDS EXPERIENCE: Strong Knowledge in pharmacovigilance With Certification or its equivalent.

Job description Should have knowledge in clinical research studies Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) should have knowledge in ICH GCP Guidelines Required Candidate profile Minimum Bachelor's or Masters degree in related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Are Applicable to Apply

Role & responsibilities: Ensures that qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical studies. Maintaining current, up-to-date curriculum vitae . Assuming responsibility for the conduct of the clinical investigation. Signing the protocol Documenting the financial aspects of the trial. Disclosing conflicts of interest as described in the regulations. Ensuring adequate number of qualified staff and adequate facilities for conductance of the study properly and safely. Ensures that all persons assisting with the study are adequately informed about the protocol, the investigational product(s), and their study-related duties and functions. Ensuring that medical care is provided to a subject for any adverse event(s) that is reported. Informing a subject when medical care is needed to treat an inter-current illness. Provide information regarding adverse events and serious adverse events to the IRB/IEC. Possessing a thorough understanding of the requirements of each protocol . Ensuring recruitment goals are reasonable and attainable. Assessing overall protocol feasibility. Following the trials randomization procedures. Ensuring that the informed consent form contains the entire Essential and additional elements required. Conduct of the clinical studies specified by the applicable regulatory requirement(s), the IRB/IEC requirements and/or the regulatory authorities. Conduct the study as per the principles of ethics and is compliance with Good Clinical Practices (GCP). Attending education workshops. Reviewing professional publications. Participating in professional societies Maintaining a list of qualified persons and their corresponding trial-related delegated duties. Preferred candidate profile can send to email: hr@qpsbioserve.com or raghavendra.kundhula@qpsbioserve.com Perks and benefits: Nil

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description: Position Summary: The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures. As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers. The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality. In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams. In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects. Principal Responsibilities: Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests. Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes. Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations. As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality. Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads. Contributes to and may lead departmental innovation and process improvement projects and may contribute programming expertise to cross functional projects/initiatives. May play the role of a Delivery Unit/Disease Area Expert. Ensures continued compliance of project/programs and required company and departmental training, time reporting, and other business/operational processes as required for position. Clinical Programming: Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards. Responsible for implementation of data tabulation standards. Performs data cleaning by programming edit checks and data review listings and Data reporting by creating data visualizations and listings for medical monitoring and central monitoring. Statistical Programming: Responsible for implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program. Principal Relationships: The Principal Programming Lead reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities. Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations. Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources. External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups. Education and Experience Requirements: Bachelors degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD). Experience and Skills Required: Approx. 6+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of programming practices (including tools and processes). Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11) Project, risk, and team management and an established track record leading teams to successful outcomes. Excellent planning and coordination of project delivery. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors. Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness adapting to rapidly changing organizations and business environments. Experience managing the outsourcing or externalization of programming activities in the clinical trials setting (e.g., Working with CROs, academic institutions) preferred experience. Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g., working with CROs, academic institutions) is preferred. Expert CDISC Standards knowledge. Expert knowledge of relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required for a Clinical Programming role. Excellent written and verbal communications and influencing and negotiation skills. Advanced knowledge of programming and industry standard data structures, thorough understanding of end-to-end clinical trial process and relevant clinical research concepts. Other: Innovative thinking allows for optimal design and execution of programming development strategies. Development and implementation of a business change/innovative way of working.

The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Clinical Data Reporting and Spotfire programming activities. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will create patient data reports and dashboards, adhering to Amgen standards, procedures, and best practices using SAS for programming and Spotfire for visualization. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams ? Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating complex Spotfire visualizations and dashboards, with the ability to justify or suggest charts based on business scenarios. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice ? Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes? Data management processes? Programming of clinical trial databases and applications? Proficient in SAS programming and Spotfire data visualization software Systems development lifecycle? Programming Languages ? Project planning and management? Collaborating with global cross-functional teams (team/matrix environment) Quality management? and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline ?with 9 to 13 yrs of experience. Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Clinical Data Reporting and Spotfire programming activities. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will create patient data reports and dashboards, adhering to Amgen standards, procedures, and best practices using SAS for programming and Spotfire for visualization. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Clinical Data Reporting and Spotfire Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams ? Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating complex Spotfire visualizations and dashboards, with the ability to justify or suggest charts based on business scenarios. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice ? Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes? Data management processes? Programming of clinical trial databases and applications? Proficient in SAS programming and Spotfire data visualization software Systems development lifecycle? Programming Languages ? Project planning and management? Collaborating with global cross-functional teams (team/matrix environment) Quality management? and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline ? Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

The Manager, CSAR - SAS Edit Check Programmer will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting SAS Edit check programming activities. The Manager, CSAR - SAS Edit Check Programmer will create and implement edit checks, adhering to Amgen standards, procedures, and best practices using SAS programming. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. The Manager, CSAR - SAS Edit Check Programmer will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, stakeholder engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence stakeholders, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following Support of clinical trial platform technologies? Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams ? Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in creating/programming complex SAS edit checks according to specifications, testing them for functionality and identify potential issues before implementation. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). Knowledge Good Clinical Practice ? Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes? Data management processes? Programming of clinical trial databases and applications? Proficient in SAS edit check programming Systems development lifecycle? Programming Languages ? Project planning and management? Collaborating with global cross-functional teams (team/matrix environment) Quality management? and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related discipline? with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena? Proven experience in managing teams General project management and planning experience ? Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelor’s degree or equivalent in life science, computer science, business administration or related discipline ?with 9-13 years of experience Proven experience in managing teams Specialist knowledge / experience in life sciences or a medically related field? General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

Manager, CSAR - Global Library Manager What you will do The Global Library Manager will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Global Library activities. They will provide Global Library review at the study level and coordinate closely with the Lead Data manager to ensure the use and adherence to Data Element Standards (DES). The Global Librarian will provide database design services to clinical study teams, in alignment with Company’s standard libraries and design practices. Ensure the standards libraries are maintained appropriately. Create and maintain standard CRFs and Edit checks in CDMS(RAVE) or other related technology. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality results, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and results at the study and library level. The CSAR Global Library Manager will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and organisational change. The successful candidate will be a strong leader with proven ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study results. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).. Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems Coordinating and providing programming support to Clinical Study Teams Maintaining standard business processes within GDO to ensure compliance to regulatory bodies Acting as a technical point of contact for systems deliverables on defined programs Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience (OR) Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience (OR) Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience Preferred Qualifications: Advanced degree in life science, computer science, math, statistics, business administration or related field Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena General project management and planning experience Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.) Knowledge: Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Systems development lifecycle Programming Languages Project planning and management Quality management Regulatory filings and inspections Understanding of CDISC and SDTM Process improvement methodologies What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, youll be at the heart of our clients innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values We believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. We prize innovation and seek intelligent solutions using leading-edge technology. Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: Bachelor s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor s degree or equivalent. At least 6 years of related experience with a master s degree or above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Strong QC / validation skills. Good ad-hoc reporting skills. Proficiency in Efficacy analysis. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data. Submissions experience utilizing define.xml and other submission documents. Experience supporting immunology, respiratory or oncology studies would be a plus. Excellent analytical & troubleshooting skills. Ability to provide quality output and deliverables, in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. How you will contribute: Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) Production and QC / validation programming Generating complex ad-hoc reports utilizing raw data Applying strong understanding/experience of Efficacy analysis Creating and reviewing submission documents and eCRTs Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries Performing lead duties when called upon Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. Being adaptable and flexible when priorities change

Sponsor-dedicated: Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, youll be at the heart of our clients innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program. Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values We believe in applying scientific rigor to reveal the full promise inherent in data. We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. We prize innovation and seek intelligent solutions using leading-edge technology. Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have: Bachelor s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor s degree or equivalent. At least 6 years of related experience with a master s degree or above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Strong SAS data manipulation, analysis and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Strong QC / validation skills. Good ad-hoc reporting skills. Proficiency in Efficacy analysis. Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data. Submissions experience utilizing define.xml and other submission documents. Experience supporting immunology, respiratory or oncology studies would be a plus. Excellent analytical & troubleshooting skills. Ability to provide quality output and deliverables, in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. How you will contribute: Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) Production and QC / validation programming Generating complex ad-hoc reports utilizing raw data Applying strong understanding/experience of Efficacy analysis Creating and reviewing submission documents and eCRTs Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries Performing lead duties when called upon Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. Being adaptable and flexible when priorities change

We are looking for a highly motivated and experienced Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 1-2 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the daily operations of the branch's receivables. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with internal teams to resolve customer complaints and issues related to payments. Analyze financial data to identify trends and areas for improvement in the bank's receivables. Ensure compliance with regulatory requirements and company policies. Maintain accurate records and reports of all transactions and interactions with customers. Job Requirements Strong knowledge of banking regulations and laws. Excellent communication and interpersonal skills. Ability to work effectively in a fast-paced environment and meet deadlines. Proficient in Microsoft Office and other software applications. Strong analytical and problem-solving skills. Ability to maintain confidentiality and handle sensitive information. Experience working in a similar role within the BFSI industry is preferred. Locaiton : - Arani,Chennai,Tiruvannamalai,Vellore

At Allucent , we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Clinical Research Associate Contractor (Sr.CRA) to join our A-team (remote). As a Sr. CRA at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. In this role your key tasks will include: Governs highest possible quality standards for trial monitoring activities. Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours. Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines: Performs efficient site management in line with study budget. Prepares and submits quality Site Visits Reports and Contact reports. Maintains and updates CTMS in compliance with SOPs and study-specific directives. Acts as Document Owner for collected documents. Conducts co-monitoring as needed. Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF). Liaises with project team members and Sponsor to track study progress and milestones. Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines. May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR). May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training. May perform assessment visits. Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel. Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution. Acts as the lead contact in case several CRAs involved for a same study in same country. Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed. May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable. May participate in meetings with clients. May support project manager/CTL and project functional leads in the project oversight and management. Supports site staff in preparation for study related site audits and inspections. Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions. To be successful you will possess: At least five years clinical monitoring experience and/or relevant clinical trial experience. Relevant life science degree / medical / nursing background, or combina

At Allucent , we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for an Investigator Payment Process Associate to join our A-team (hybrid*). As an Investigator Payment Process Associate at Allucent, you will be responsible for supporting the Investigator Payments process, using our Veeva Payments system and leading the development of Standard Operating Procedures (SOP). Process investigator-related invoices in Veeva and our Dynamics 365 accounting system. Provide regular status reports to the Finance and Project Management teams and communicate with stakeholders, investigator sites and sponsors, to ensure smooth processing of IP. Meeting timelines globally and ensuring compliance with all IP processes and procedures, including documenting and maintaining all manuals as needed. In this role your key tasks will include: Working along with IP Specialist on the IP sub-processes Verify the IP invoice entry in D365 with actual invoice and ensure correct coding Support team members in entering IP invoices Investigator Payments data loading for US, EU, and APAC countries into Veeva Support the Veeva payments system upgrades and configuration changes Quality check/QC Fee Schedules in Veeva Handle site invoices and queries received through email Coordinate on escalation emails Circulate outstanding invoices reports to team. Host/coordinate call with Clinical/IT team for new study fee schedule creation in Veeva Creating/Approving Fee schedules in Veeva based on the contract Weekly/Monthly generating payment request for payable items in Veeva and route to clinical team for approval Weekly paid investigator invoices reports are pulled from Power BI and circulated to Team Circulating Study related reports to Clinical teams Site visit, invoice, and payment reconciliations Prepare Sunshine reporting for project teams and sponsors. To be successful you should possess: A bachelors degree with a major or concentration in accounting is required. Advanced degrees or accounting certifications are a plus. 4 + years of Inve

We are looking for a highly skilled and experienced Relationship Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-4 years of experience in the BFSI industry, preferably in micro mortgages. Roles and Responsibility Manage relationships with existing clients to ensure timely payment of EMIs and minimize defaults. Identify new business opportunities through networking and referrals to expand the client base. Conduct site visits to assess client needs and provide personalized solutions. Develop and implement strategies to increase sales revenue from existing clients. Collaborate with internal teams to resolve customer queries and issues promptly. Maintain accurate records of client interactions and transactions. Job Requirements Strong knowledge of micro mortgage products and services. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong analytical and problem-solving skills. Proficiency in using technology and software applications. Experience in relationship management and sales is desirable.

Key Responsibilities: - Provide Regulatory Advisory and Advocacy and getting clarity from the Exchanges on regulatory circulars / guidelines and provide the same to various functions in the organisation - Review and defining processes for implementation of various circulars issued by Exchanges, Depositories, SEBI etc. - Day to day query handling in relation to regulatory area of SEBI, Exchanges & Depositories. - Conduction Audit /review of various activity for Broking, DP, PMS & Branch inspections - Handling Regulatory Inspections & Internal Audit Independently - Liaison with Regulators - Ensuring timely & accurate regulatory submission to exchanges, Depositories, various PMS submission etc. - Preparing various reports & MIS for Senior Management & Board of Directors - Responsible for framing internal policies, procedures, standards, and processes and ensure implementation of the same. - Assessing the compliance risks faced by the business and to ensure that the organisation appropriately manages those risks. - Overseeing and monitoring the implementation of the compliance program - Provide compliance opinions to the functions in the organisation on applicability of regulatory laws in relation to activities of the organisation - Promoting a compliance culture - Providing guidance, advice, and/or training and educational programs, to improve business' understanding of related laws and regulatory requirements - Coordinating and participating in the development of measures aimed at reducing the level of compliance risk. Forming, maintaining and controlling the system of internal control and compliance risk management, system for correction of identified violation- Oversee and monitor the Control risks viz. a viz. organisation standards and local regulatory environment, identify breaches and suggest/ implement mitigation measures.- Review and regular update of policies and procedures in view of new regulations including compliance manuals.- Liase with the Regulatory functions to resolve the issues and queries that organisation may be experiencing.- Handle investigations, inspection related matters and provide support to the team handling inspections, investigations, and other regulatory matters.- Engage in the Compliance Advocacy on the issues as well as on the consultation papers issued by the Regulators.- Provide support to Compliance function to address any issues faced in Regulatory filings and other operational Compliance matters- Handle regulatory investigations, queries, and ad-hoc matters along with Legal- Lead the team and guide them to perform their duties effectively in this function- Act as a back-up for the senior roles in the other Compliance related functions

1.1 Job Description The research associate will need to gather Information from publicly available resources as well as commercial resources. 1.2 Responsibilities Gathering data from primary and secondary sources of information. secondary searches using various sources like doctor homepage, PubMed, conference, Association, Industry or Pharma companies, etc) Verification and Validation of physician/doctor information for appropriate Affiliation, Specialty, Nationality & Postal code Reporting to Team Leader 1.3 Skills Technical understanding in life science related information like therapeutic area, specialty. Self-starter with good interpersonal, comprehensive and communication skills. Good grasp and understanding & explaining capabilities Web research capabilities Proficient in Microsoft Office (Word, PowerPoint, Excel) Experience and basic skills in searching for scientific data and information Strong attention to detail and a strong analytical mind

We are looking for a highly motivated and experienced Branch Sales Manager to lead our retail mortgage team in Equitas Small Finance Bank Ltd. The ideal candidate will have a strong background in sales management, preferably in the BFSI industry, with 3-8 years of experience. Roles and Responsibility Develop and implement effective sales strategies to achieve business objectives. Lead and manage a team of sales professionals to meet targets. Build and maintain relationships with key stakeholders, including customers and partners. Analyze market trends and competitor activity to identify opportunities. Collaborate with cross-functional teams to drive business growth. Monitor and control expenses to ensure profitability. Job Requirements Proven experience in sales management, preferably in the BFSI industry. Strong knowledge of retail mortgages and related products. Excellent leadership and communication skills. Ability to analyze market trends and develop effective sales strategies. Strong relationship-building and negotiation skills. Experience in managing and motivating a team to achieve targets.

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 3 years of experience in the BFSI industry. Roles and Responsibility Conduct risk assessments and evaluations to identify potential threats to the organization. Develop and implement strategies to mitigate risks and ensure compliance with regulatory requirements. Collaborate with cross-functional teams to monitor and report on risk performance metrics. Analyze market trends and competitor activity to inform risk management decisions. Provide expert guidance on risk management best practices to stakeholders. Identify and assess new business opportunities to drive growth and expansion. Job Requirements Strong understanding of risk management principles and practices. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a fast-paced environment and prioritize multiple tasks. Strong communication and interpersonal skills, with the ability to build relationships with stakeholders. Experience working with financial data and analytics tools is an asset. Bachelor's degree in any discipline; relevant certifications or training programs are desirable.

Looking to onboard a skilled Relationship Manager with 1 to 6 years of experience to lead our Mutual Funds Collections team in the BFSI sector. The ideal candidate will have a strong background in managing relationships and driving business growth. Roles and Responsibility Develop and implement effective strategies for mutual funds collections. Build and maintain strong relationships with clients and stakeholders. Identify new business opportunities and drive revenue growth. Collaborate with cross-functional teams to achieve business objectives. Analyze market trends and competitor activity to stay ahead in the industry. Provide exceptional customer service and support to clients. Job Requirements Minimum 1 year of experience in relationship management or a related field. Strong knowledge of the BFSI sector, particularly mutual funds collections. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet deadlines. Strong analytical and problem-solving skills. Experience working with Equitas Small Finance Bank Ltd is an added advantage.

We are looking for a highly skilled and experienced Branch Manager to lead our team in Equitas Small Finance Bank Ltd. The ideal candidate will have a strong background in BFSI, with 5-10 years of experience. Roles and Responsibility Manage daily branch operations, ensuring efficient use of resources and adherence to regulatory requirements. Develop and implement strategies to achieve business objectives, including sales growth and customer acquisition. Lead and motivate a team of banking professionals, providing guidance on product knowledge and customer service standards. Build and maintain relationships with key stakeholders, including customers, colleagues, and external partners. Monitor and control expenses, ensuring cost-effectiveness without compromising quality or service delivery. Identify opportunities for process improvements, implementing changes to increase productivity and efficiency. Job Requirements Strong understanding of BFSI industry trends, regulations, and best practices. Excellent leadership and management skills, with the ability to inspire and guide teams. Proven track record of achieving business objectives through strategic planning and execution. Strong analytical and problem-solving skills, with attention to detail and accuracy. Effective communication and interpersonal skills, enabling building strong relationships with stakeholders. Ability to work in a fast-paced environment, prioritizing tasks and managing multiple responsibilities.

We are looking for a skilled Relationship Manager to join our team at Equitas Small Finance Bank Ltd in the BFSI industry. The ideal candidate will have 3-6 years of experience and a strong background in retail mortgages. Roles and Responsibility Manage and maintain relationships with existing clients to ensure customer satisfaction and retention. Identify new business opportunities and develop strategies to acquire new customers. Conduct market research and analyze competitor activity to stay ahead in the market. Collaborate with internal teams to provide excellent customer service and support. Develop and implement sales plans to achieve targets and goals. Build and maintain a strong network of contacts within the community. Job Requirements Proven experience in relationship management, preferably in the BFSI industry. Strong knowledge of retail mortgages and financial products. Excellent communication and interpersonal skills. Ability to work in a fast-paced environment and meet deadlines. Strong analytical and problem-solving skills. Experience working with small finance banks or similar institutions is an advantage.

We are looking for a highly skilled and experienced Branch Receivable Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 3 to 8 years of experience in the BFSI industry, with expertise in managing receivables and driving business growth. Roles and Responsibility Manage and oversee the daily operations of the branch's receivable functions. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with cross-functional teams to identify and mitigate potential risks. Analyze and report on key performance indicators (KPIs) related to receivables and collections. Ensure compliance with regulatory requirements and internal policies. Lead and motivate a team of professionals to achieve business objectives. Job Requirements Strong knowledge of BFSI regulations and practices. Proven experience in managing receivables and driving business growth. Excellent leadership and communication skills. Ability to analyze complex data sets and make informed decisions. Strong problem-solving and negotiation skills. Experience working in a fast-paced environment and meeting deadlines.

RoleClinical & Therapy Development Manager Type Full Time Job description - Successfully complete our internal training plan to include hemodynamics, ECG, angiography, echo CT imaging modalities and complete the case support and proctor delegate authorizations. - Provide active commercial case support, demonstrating excellence in procedural success rates patient outcomes. - Scrub in sterile and provide TAVI valve loading in procedures training instruction to trial and commercial customers - Provide our customers CT valve sizing analysis utilizing the Pie Medical 3Mensio CT program - Lead customer didactic education sessions for account activation before first implants - Lead pre case planning debriefing of heart team pre post procedure and provide ongoing education as requested for proper in - service levels - Provide documentation as required for quality assurance initiatives - Co-develop commercial business plan for assigned region - Co-support internal/external quarterly business reviews - Data entry into Salesforce, Mentor software for customer case support management - Learn commercial data analytics, resources tools for effective customer experience - Support customer engagement strategy with Marketing team (TM)) - Demonstrate competency with marketing messaging, clinical evidence and medical education portfolio offering - Demonstrate knowledge in the TAVI market, industry competitive insights - Participate in team meetings, conventions, and national sales meetings as requested - Drive innovative marketing and referral activities in collaboration with the markeitng team - Collaborate with the Sales and marketing team to conduct targeted market development in India Sub-continent. - Lead organization and delivery of key symposia by supporting discussions with customers to define agenda topics, select appropriate speakers / chairs, create required materials for events. - Develop Key Opinion Leaders within this segment to create market for the new therapies which will be launched and create advocates for your product who will speak on various forums - Identify high potential international / national referral community meetings to target for market development and collaborates with sales management team to put forward case for investment (program contributions / symposiums / workshops) This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

We are looking for a highly skilled and experienced Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 3 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the daily operations of the branch's receivables. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with internal teams to resolve customer complaints and issues. Analyze and report on receivable performance metrics to senior management. Ensure compliance with regulatory requirements and company policies. Maintain accurate records and reports of all transactions. Job Requirements Strong knowledge of financial regulations and laws governing the BFSI industry. Excellent communication and interpersonal skills for effective customer interaction. Ability to work independently and as part of a team to achieve goals. Strong analytical and problem-solving skills to resolve complex issues. Proficiency in Microsoft Office and other software applications. Experience in managing and leading a team to achieve high performance standards.