Job
Description
Role Overview: As a Medical Oversight professional, you will be responsible for providing ongoing medical monitoring of assigned clinical trials. This includes conducting real-time safety reviews of adverse events (AEs) and serious adverse events (SAEs) to ensure participant well-being. You will evaluate safety signals, trends, and laboratory/ECG abnormalities, and provide independent medical judgment when necessary. Key Responsibilities: - Contribute to the development of clinical protocols, including writing, amending, and reviewing study-related documents such as Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and Statistical Analysis Plans (SAPs). - Engage with Key Opinion Leaders (KOLs) to ensure protocol design is scientifically rigorous, ethical, and compliant with regulatory expectations. - Assist in the creation of informed consent forms and patient information sheets to uphold ethical standards. - 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 effectively. - Serve as a core member in coordinating activities with Steering committees and Data Safety Monitoring Boards (DSMBs) as required. - Offer medical expertise to investigators, study teams, and Contract Research Organization (CRO) partners during site initiation, monitoring visits, and audits. - Review inclusion/exclusion decisions for complex or borderline cases and facilitate the resolution of protocol deviations with appropriate corrective/preventive actions. - Ensure that clinical studies adhere to International Council for Harmonisation - Good Clinical Practice (ICH-GCP) guidelines, relevant regulatory requirements, and ethical guidelines. - Provide medical input for regulatory submissions, responses to health authority queries, and activities related to inspection readiness. - Collaborate with various departments like clinical operations, data management, biostatistics, and project management to ensure high-quality trial execution. - Deliver medical training sessions to internal teams and site staff as needed. Qualifications Required: - Education: MD (or equivalent medical degree); board certification or specialty training preferred (e.g., oncology, cardiology, internal medicine, or other relevant field). - Experience: A minimum of 3 years of clinical research experience in pharmaceuticals, biotechnology, or Contract Research Organizations (CROs) in areas such as clinical development, medical affairs, or pharmacovigilance. Direct experience as a medical monitor or safety physician is advantageous. - Knowledge: Possess an in-depth understanding of clinical trial methodology, ICH-GCP guidelines, and regulatory requirements from authorities such as the FDA, EMA, and CDSCO. Familiarity with safety reporting requirements and the drug development lifecycle is essential. Role Overview: As a Medical Oversight professional, you will be responsible for providing ongoing medical monitoring of assigned clinical trials. This includes conducting real-time safety reviews of adverse events (AEs) and serious adverse events (SAEs) to ensure participant well-being. You will evaluate safety signals, trends, and laboratory/ECG abnormalities, and provide independent medical judgment when necessary. Key Responsibilities: - Contribute to the development of clinical protocols, including writing, amending, and reviewing study-related documents such as Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and Statistical Analysis Plans (SAPs). - Engage with Key Opinion Leaders (KOLs) to ensure protocol design is scientifically rigorous, ethical, and compliant with regulatory expectations. - Assist in the creation of informed consent forms and patient information sheets to uphold ethical standards. - 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 effectively. - Serve as a core member in coordinating activities with Steering committees and Data Safety Monitoring Boards (DSMBs) as required. - Offer medical expertise to investigators, study teams, and Contract Research Organization (CRO) partners during site initiation, monitoring visits, and audits. - Review inclusion/exclusion decisions for complex or borderline cases and facilitate the resolution of protocol deviations with appropriate corrective/preventive actions. - Ensure that clinical studies adhere to International Council for Harmonisation - Good Clinical Practice (ICH-GCP) guidelines, relevant regulatory requirements, and ethical guidelines. - Provide medical input for regulatory submissions, responses to health authority queries, and activities related to inspection readiness. - Collaborate with various departmen
