Clinical Research Physician

1 week ago

Jamnagar, India Micro Crispr Pvt. Ltd. Full time

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.

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