Job Description

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...

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