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 an

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