Senior Clinical Project Manager

0 years

0 Lacs

Posted:1 month ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Responsibilities


  • Formulate & review design of clinical trial studies for biosimilars with reference to regulatory guidelines, innovator studies & similar drug trials
  • Incharge of execution of clinical trials for biosimilars in coordination with CROs
  • Identify & appoint medical advisors and obtain inputs for sponsor-side medical monitoring of study
  • Internal coordination for IP supply and logistics management, analytical method development and central lab analysis
  • Comply to regulatory requirements with submissions, follow-up & approvals in coordination with RA dept and CRO
  • Take care of Pharmacovigilance processes with timely reporting of ADRs & responding to market complaints
  • Serve as chief contact for Govt grant projects with submission of RFPs, periodic reports & presentations in coordination with the project Principal investigator.

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