Clinical Data Management Specialist

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 [Confidential Information] & [HIDDEN TEXT]