HR Senior Executive at Stempeutics Research Pvt Ltd
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Medical Affairs Role - Pharmacology - MD (4-7 yrs)
Job Description :
1) Should be a medical doctor - preferably with MD in Pharmacology
2) 4+ years- experience in handling Phase 2/Phase 3 clinical trials in India
3) Manage the CRO team for all clinical trial activities. Handle queries from CRO / site / Ethics committees
4) Protocol Development and Review of study documents (protocol, ICF, CRF, IB, SAP and CSR) to ensure safety, regulatory and ethical compliance as per existing guidelines
5) Provide medical training to clinical staff in general medical issues, investigator meeting presentations, ongoing training for project teams in therapeutic areas
6) Resource allocation for review projects
7) Review efficacy evaluations at clinical trial sites - provide feedback for improvement and protocol compliance
8) Planning of clinical development programs for the company's biological products
9) Support the CRO during initiation and conduct of trial, monitoring visits
10) Tracking the safety information and maintaining pharmacovigilance data base.
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