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 gaurangna@latinumhr.com & jobs@ats.latinumhr.com

Work arrangement
Hybrid