Sr. Executive / Asst. Manager - Clinical Trials management
AhmedabadFull-time5–7 yrsPosted over a month ago
Senior pharma role at Hcfa in Ahmedabad. Needs 5–7 years and an M.Pharm.
About the role
Scientific review of Protocol and related documents i.e ICF, CRF, Plans, logs and forms, etc. as per regulatory requirements. Oversight monitoring of the study data across all sites. Resolved all issues identified during the monitoring visit after discussion with CRO to best of interest of the study.
What you'll do
- Review of SIV presentations prepared by CRO and check for its compliance with protocol and applicable regulatory requirements
- Accompany CRO personnel for SIV and resolve all queries raised during SIV for smooth execution of the study
- Tracking patient recruitment and pushing the CRO for timely delivery of the project
- Track and process on CRO’s payment as per defined milestone in agreement
- Accompany CRO personnel for closeout visit and resolve all outstanding queries raised during monitoring visit
What you need
- Clinical research
- Pharmacology
- CRO
- Learning and development
- Performance management