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 (India)
🏢 Latinum Hr Solutions
📍 India