Medical Oversight
- Provide ongoing medical monitoring of assigned clinical trials, including real-time safety review of adverse events (AEs) and serious adverse events (SAEs).
- Evaluate safety signals, trends, and laboratory/ECG abnormalities to ensure participant well-being.
- Assess investigator-reported causality and provide independent medical judgment when required.
2. Protocol Development and Study Design
- Contribute to clinical protocol writing, amendments, and study-related documents (IB, CSR, SAP).
- KOL engagement
- Ensure protocol design is scientifically rigorous, ethical, and aligned with regulatory expectations.
- Participate in the development of informed consent forms and patient information sheets.
3. Safety Management
- Support the preparation and review of safety narratives, Development Safety Update Reports (DSURs), and periodic safety reports.
- Collaborate with pharmacovigilance teams to manage safety data and address regulatory safety queries.
- Serve as a core member for the coordination with Steering committee, DSMB etc. as applicable.
4. Study Conduct and Medical Support
- Provide medical expertise to investigators, study teams, and CRO partners during site initiation, monitoring visits, and audits.
- Review inclusion/exclusion decisions for complex or borderline cases.
- Support resolution of protocol deviations and ensure appropriate corrective/preventive actions.
5. Regulatory and Ethical Compliance
- Ensure studies comply with ICH-GCP, applicable regulatory requirements, and ethical guidelines.
- Provide medical input to regulatory submissions, responses to health authority queries, and inspection readiness activities.
6. Cross-Functional Collaboration
- Partner with clinical operations, data management, biostatistics, and project management to ensure high-quality trial execution.
- Deliver medical training to internal teams and site staff as required.
Qualifications & Requirements
- Education: MD (or equivalent medical degree); board certification or specialty training preferred (e.g., oncology, cardiology, internal medicine, or other relevant field).
- Experience:
- 3+ years of clinical research experience in pharma, biotech, or CRO (clinical development, medical affairs, or pharmacovigilance).
- Direct experience as a medical monitor or safety physician preferred.
- Knowledge:
- In-depth understanding of clinical trial methodology, ICH-GCP, regulatory guidelines (FDA, EMA, CDSCO, etc.).
- Familiarity with safety reporting requirements and drug development lifecycle.
