Clinical Data Management - Associate Manager

n

nExperience: 7+ Years

nLocation: PAN India

nBudget : 30 LPA

nQualification: Associate or Bachelor’s Degree preferred

nIndustry: Clinical Research / Pharmaceutical / Biotechnology

n

nKey Responsibilities :

n

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




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

n

nTeam Coordination and Mentoring

n

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

n

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

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