CLINICAL HEAD

Location : Mira Road, Mumbai

Minimum Qualification : MBBS

Roles and Responsibilities :

1. To lead and manage multiple clinical studies to ensure studies are delivered within agreed budget, schedule and quality requirements.

2. To motivate and inspire team members to keep the projects on track to a successful outcome and capitalize on opportunities arising throughout the lifecycle of the project.

3. Be assertive, persistent, detail oriented, and comfortable interacting with subject matter experts from within the clinical research industry

4. Listing out protocol deviations and incorporate the same in final report in consultation with the Principal Investigator.

5. To prepare reports eCTD format

6. Handling of regulatory/ sponsor/ QA findings and compliance check procedure

7. To monitor Dosing and Dispensing activity,

8. Preparing clinical study reports as per applicable guideline and sponsors requirements in coordination with the Principal Investigator

9. Compilations of the project reports with applicable appendices

10. To Review of draft protocols, CRFs, ICFs and Clinical study Reports

11. To carry out physical examination of the volunteers and report the same in appropriate forms for the proposed BA/BE trial.

12. To decide upon the inclusion of volunteer depending on the clinical findings in accordance to eligibility criteria's as per protocol.

13. To monitor and record the vital signs and symptoms of the subjects at regular intervals as per the protocol of the study.

14. Counseling of Volunteers.

15. To give inputs for preparation quotation (Project Feasibility)

16. Study monitoring abilities

17. To address the Adverse Event's, (if any) and report the same.

18. Should have good communication skills, project planning and co-ordination skills

Interested candidates can send their cv 

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.