Amneal Pharmaceuticals

Deputy Manager / Manager - Clinical Trials management

Amneal Pharmaceuticals  •  Ahmedabad, IN (Onsite)  •  5 months ago
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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.

M. Pharm (Clinical Pharmacy/Pharmacology)

5-7 years' Experience

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.

Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

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Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
Website
amneal.com
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