Latinum HR Solutions
Website:
latinumhr.com
Job details:
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
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