Role-Clinical Data Manager

- Evaluation of data management capabilities of CRO/vendors/service providers and due diligence.
- Design of annotated CRF, EDC as per protocol requirement.
- Manage all aspects of clinical data management such as query management, discrepancy management, UAT, Edit Check in development of EDC.
- Creation, review, approval of data management documents for project set-up, conduct and close out phases.
- Set KPIs and oversee the clinical data management deliverables of CROs/Vendors.
- Ensure project team and CRO adhere to the timelines and deliverables.
- Define data review requirements and processes to ensure delivery of highest quality data.
- Review clinical study data/listings including TLFs.




- Oversee and guide CRO during data base lock.
- Set risk and mitigation plan for data management related deliverables.
- Oversees Clinical data migration and reconciliation from one system to another system.
- Keep abreast on current technologies available on holistic review of data and ways to improve efficiencies in data review to improve data quality.
- Undertake SOP preparation/review required for clinical development.

14.12–13 years of overall experience in Clinical Data Management within sponsor and/or CRO environments.

📌 Manager (India)
🏢 BIOCON BIOLOGICS
📍 India