Job Description Role-Clinical Data Manager
n 1. Evaluation of data management capabilities of CRO/vendors/service providers and due diligence.
n 2. Design of annotated CRF, EDC as per protocol requirement.
n 3. Manage all aspects of clinical data management such as query management, discrepancy management, UAT, Edit Check in development of EDC.
n 4. Creation, review, approval of data management documents for project set-up, conduct and close out phases.
n 5. Set KPIs and oversee the clinical data management deliverables of CROs/Vendors.
n 6. Ensure project team and CRO adhere to the timelines and deliverables.
n 7. Define data review requirements and processes to ensure delivery of highest quality data.
n 8. Review clinical study data/listings including TLFs.
n 9.



Oversee and guide CRO during data base lock.
n 10. Set risk and mitigation plan for data management related deliverables.
n 11. Oversees Clinical data migration and reconciliation from one system to another system.
n 12. Keep abreast on recent technologies available on holistic review of data and ways to improve efficiencies in data review to improve data quality.
n 13. Undertake SOP preparation/review required for clinical development.
n 14.12–13 years of overall experience in Clinical Data Management within sponsor and/or CRO settings.

📌 Manager Bengaluru (India)
🏢 BIOCON BIOLOGICS
📍 India