Sr Manager/AGM - Clinical Pharmacology and Medical Affairs

Role & responsibilities

1. Act as a Principal Investigator / Co-investigator

2. Responsible for overall clinical conduct of studies at Mehsana.

3. Prepare and review protocols for clinical studies

4. Co-ordinate activities related to IEC

5. Communicate IEC related issues to all concerned

6. Ensure compliance to protocol, SOPs and Regulatory requirements

7. Coordinate with Project Coordinators for all project related matters

8. Monitor and manage adverse events

9. Clinical examination and eligibility of subjects during screening

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

11. Ensure timely response to QA findings

12. Interact with sponsors on medical related matters

13. Handle safety related issues and ensure appropriate communication

14. Prepare and review reports for clinical studies

15. Write and review related SOPs

16. Contribute towards scientific development of the organization

17. Handle medical confidential report and case management

18. Maintain and update all the systems and SOPs in the department

19. Train the staff on CPR, GCP and related guidelines and all departmental and relevant SOPs 20. Monitor and co-ordinate for volunteer recruitment and screening procedures

21. Any other responsibilities as assigned by the Head of Department/ Management.