Provide therapeutic and scientific content for development of trial protocols
Provide medical oversight regarding protocol exemptions, protocol violations, protocol eligibility issues, accepted medications, and general medical-related study issues
Address queries from investigators, coordinators, and research monitors
Prepare Serious Adverse Event form as per study protocol and the SAE reconciliation plan
Conduct medical review of SAP, Project Plan, Tables and Listings, and Clinical Study Reports
Conduct training for project team concerning the disease, drug, study design and procedures
Review site monitoring activities and suggest corrective actions for discrepancies
Required Candidate profile
Candidate must be B.Pharma/M.Pharma/M.Sc./MBBS with relevant experience in Clinical Research.
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology, Role Category: R&DRole: R&DEmployement Type: Full time
Education
Under Graduation: B.Pharma in PharmacyPost Graduation: M.Pharma in PharmacyDoctorate: Doctorate Not Required, Any Doctorate