Principal Investigator - Clinical Pharmacology and Medical Affairs

Role & responsibilities

1. Act as a Principal Investigator / Co-investigator in phase-1 studies, Biosimilar and BA/BE studies in all therapeutic area as well as various kind of formulation.

2. Feasibility assessment of different molecules as per request from sponsors.

3. Conducted complex BA/BE study at hospital site as Principal Investigator.

4. Involved in Audit/Inspection handling and Projects conducted as Principal Investigator have been audited and cleared by different regulatory.

5. Leading and guiding the Research Staff as Team Lead.

6. Prepare and review protocols for clinical studies

7. Ensure compliance to protocol, SOPs and Regulatory requirements

8. Communicate IEC related issues to all concerned

9. Coordinate with Project Coordinators for all project related matters

10. Monitor and manage adverse events

11. Coordinate with panel of consultants to seek medical opinion as and when required

12. Ensure timely response to QA findings

13. Interact with sponsors on medical related matters

14. Handle safety related issues and ensure appropriate communication

15. Prepare and review reports for clinical studies

16. Overall supervision of screening and check-in activities

17. Write and review related SOPs

18. Contribute towards scientific development of the organization

19. Support clinical trial group

20. Handle medical confidential report and case management

21. Help maintain and update all the systems and SOPs in the department

22. Train the staff on CPR, GCP and related guidelines and all departmental and relevant SOPs.

23. Any other responsibilities as assigned by the Head of the Department