Clinical Data Coordinator II/ Clinical Data Manager I Under the direction of the Clinical Data Management (CDM) Lead, the Associate Manager Clinical Data Management performs tasks to support the clinical trial data management life-cycle from study start-up through database lock and study close-out. Under the direction of the CDM Lead, the Associate Manager Clinical Data Management contributes to the successful conduct of clinical trials and to the delivery of high quality and timely data, which are used in statistical analysis and then submitted to regulatory authorities for the approval of products. Key Accountabilities: Under the direction of the CDM Lead or delegate, performs data management tasks according to applicable SOPs (standard operating procedures) and processes. These activities may include the following categories: Data Review
• May perform one of more of the following:
• Performs data review of clinical trial data, including query management. Communicates with Sponsor study team members and CRO (Contract Research Organization) to resolve queries.
• Performs detailed review of eCOA/external data per the Date Review Plan and works closely with the vendor and CRO to resolve eCOA/external data related issues. May include the following:
• Acts as liaison between Sponsor, CRO and eCOA vendor/external data vendor.
• Ensures accessibility of eCOA/external data to all relevant sponsor and CRO team.
• QCs a sample of data clarification requests processed by the eCOA/external data vendor.
• Maintains eCOA/external data issues within the centralized study data issues log.
• Ensures appropriate and timely communication of eCOA/external data related issues and resolutions to relevant Sponsor and CRO team.
• Performs reconciliation review of eCOA/external data against EDC data and works with applicable parties to resolve queries.
• Performs SAE (Serious Adverse Event) reconciliation and communicates with applicable safety team members to resolve issues.
• May prepare and distribute performance metrics (e.g. site completion of data entry and resolution of queries) to applicable stakeholders. Escalates to CDM Lead and study team as needed.
• Contributes to the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.
• Performs additional review activities for interim and final database locks as needed. Documentation & Filing
• Files study documentation in electronic Trial Master File (eTMF) and department project files.
• Performs periodic quality review of eTMF documents.
• Assists with taking meeting minutes and documenting/tracking study data management activities.
• Performs data archival activities.
• Performs inspection readiness activities and supports CDM team during internal and regulatory inspections Data Collection Systems
• Supports the set-up and testing of study data collection tools such as EDC (electronic data capture), IRT (interactive response technology), eCOA (electronic clinical outcome assessment), ePRO (electronic patient reported outcomes),



and creation/maintenance of associated documentation.
• May contribute to the creation and maintenance of study eCRF Completion Guidelines and other data collection tool guidelines.
• May assist with management of account access and training materials for data collection tools Additional Activities
• Assists with quality review of above activities performed by the CRO, as needed.
• Coordinates and oversees the work of other data coordinators.
• Mentors other data coordinators.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
• Performs other duties as assigned. Educational Qualifications
• Associate or Bachelor's Degree preferred Experience
• Understanding of clinical trial documents (protocols, case report forms, data management plans, study reports) and processes
• Preferred 2-5 years relevant work experience, or equivalent combination of training and experience.
• Preferred experience in data management/drug development within GCP/clinical research regulatory environment.
• Experience with electronic data collection systems.
• Experience managing multiple work deliverables and deadlines.
• Knowledge of data management best practices & technologies as applied to clinical trials.
• Knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. Clinical Data Manager I/ Senior Clinical Data Manager The Manager Clinical Data Management is responsible for timely and high-quality data management deliverables supporting the portfolio. They conduct oversight of Data Management activities at the project level performed by sponsor or Strategic Partners, CROs or other 3rd Party Vendors to ensure they meet obligations as described in ICH-GCP and Sponsor's Scope of Work. They drive adherence to CDM processes and high ethical standards
- from protocol synopsis through database release and submission. The Manager Clinical Data Management serves as an expert for clinical data management best practices, engages with cross-functional team members to perform proper Data Reviews and acts as an ambassador on CDISC standards. Key Accountabilities
• Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and sponsor for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality.
• Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
• For studies where data management activities are conducted within sponsor, leads and manages clinical trial data collection set-up, data review, and database lock: (a)



Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO and eCOA. (b) Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans. (c) Leads data review, including query management, and leads activities required for interim and final database locks.
• Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones.
• Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
• May prepare metrics to support the function’s KPIs.
• Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of sponsor.
• Contributes to functional Continuous Improvement initiatives, providing expertise and ensuring deliverables are provided on time, to budget, and in alignment with company, departmental or functional requirements.
• Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables
• Champions and adopts technology improvements and tools for use in clinical data management processes.
• Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
• Performs other duties as assigned. Educational Qualifications
• BS/BA required preferably in a health-related, life science area or technology-related fields. Experience
• Preferred 4 plus years or experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
• Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
• NDA/CTD Experience preferred.
• Strong knowledge of data management best practices & technologies as applied to clinical trials.
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. Special Skills/Abilities
• Good understanding of CDISC standards. Some experience in standards development, implementation and maintenance is ideal.
• Advanced knowledge of office software (Microsoft Office).
• Robust knowledge of relational databases and experience using multiple clinical data management systems.
• Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models

📌 Clinical Data Coordinator II/ Clinical Data Manager/ Senior Clinical Data Manager (India)
🏢 Veramed
📍 India