Sr. Executive / Asst. Manager - Clinical Trials management

Amneal Pharmaceuticals · Ahmedabad

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.

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. Candidate must have exposure of Clinical trial operation and have handled patient PK and CEP study.

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