Manager

Biocon Biologics · Bangalore g.p.o., India

Role-Clinical Data Manager

1. Evaluation of data management capabilities of CRO/vendors/service providers and due diligence.

2. Design of annotated CRF, EDC as per protocol requirement.

3. Manage all aspects of clinical data management such as query management, discrepancy management, UAT, Edit Check in development of EDC.

4. Creation, review, approval of data management documents for project set-up, conduct and close out phases.

5. Set KPIs and oversee the clinical data management deliverables of CROs/Vendors.

6. Ensure project team and CRO adhere to the timelines and deliverables.

7. Define data review requirements and processes to ensure delivery of highest quality data.

8. Review clinical study data/listings including TLFs.

9. Oversee and guide CRO during data base lock.

10. Set risk and mitigation plan for data management related deliverables.

11. Oversees Clinical data migration and reconciliation from one system to another system.

12. Keep abreast on new technologies available on holistic review of data and ways to improve efficiencies in data review to improve data quality.

13. 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.