Clinical Data Management - Associate Manager

Experience: 7+ Years

Location: PAN India

Budget : 30 LPA

Qualification: Associate or Bachelor's Degree preferred

Industry: Clinical Research / Pharmaceutical / Biotechnology

Key Responsibilities

- Manage clinical data management activities from study start-up through database lock and study close-out. - Perform clinical trial data review to ensure data accuracy, completeness, consistency, and quality. - Manage clinical data queries and coordinate with sites, CROs, and study teams for resolution. - Review eCOA and external data as per the applicable Data Review Plan. - Coordinate with eCOA and external data vendors to resolve data-related issues. - Perform reconciliation of eCOA/external data against EDC data. - Perform SAE reconciliation and coordinate with Safety/PV teams for issue resolution. - Prepare and monitor study-level performance metrics and data quality indicators. - Contribute to study data cleaning plans and data validation/edit-check specifications. - Support listing review checks and clinical data review activities. - Develop and maintain data integration and data transfer specifications. - Support external data reconciliation plans and SAE reconciliation guidelines.



- Contribute to database lock plans and perform interim/final lock activities. - Support setup, testing, and maintenance of EDC, IRT, ePRO, and eCOA systems. - Contribute to eCRF Completion Guidelines and other data collection documentation. - Provide oversight and quality review of CDM activities performed by CROs and vendors. - Maintain study documentation in eTMF and support inspection-readiness activities. - Coordinate and oversee the work of data coordinators and provide mentoring as required. - Manage multiple CDM deliverables, timelines, issues, and stakeholder communications. - Ensure compliance with SOPs, GCP/GxP, FDA, ICH, and applicable clinical data management standards.

Team Coordination and Mentoring

- Coordinate and oversee the work of other data coordinators. - Provide guidance and mentoring to junior members of the CDM team. - Support quality review of activities performed by other team members and CROs. - Manage multiple study deliverables and deadlines effectively. - Collaborate with cross-functional teams to ensure timely completion of CDM deliverables.

Interested candidates can share their updated CV at [email protected] & [email protected]

📌 Clinical Data Management Specialist (Hyderabad)
🏢 Latinum Hr Solutions
📍 Hyderabad