Clinical Research Physician

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.