Sr. Executive / Asst. Manager - Clinical Trials management

Amneal Pharmaceuticals India · Ahmedabad

Source and collection record

Last observed by our collector: 8 October 2026 at 11:04 pm IST. This is not a manual review or a confirmation from the employer.

Employer requisition: 6812

Job type and experience labels are automated discovery categories. The employer determines eligibility. Original experience wording was not retained separately; check the current employer page.

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Collected minimum qualification: M. Pharm (Clinical Pharmacy/Pharmacology)Attendance and availability: I checked the employer page for work location, office attendance, start date and duration.Current requisition: I checked the current employer requisition and its application requirements.

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Collected role description

Candidate must have exposure of Clinical trial operation and have handled patient PK and CEP study. Job Description: Scientific review of Protocol and related documents i.e ICF, CRF, Plans, logs and forms, etc. as per regulatory requirements. Review of SIV presentations prepared by CRO and check for its compliance with protocol and applicable regulatory requirements. Should have knowledge of various EDC platforms and can do review of eCRF for edit checks. 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. 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. 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. Should have experience in handling patient PK and CEP study for regulated market i.e USFDA, EU, Canada Scientific review of Clinical Study Report.

Collected minimum qualification

M. Pharm (Clinical Pharmacy/Pharmacology)

Collected experience requirement

5-7 years' Experience