Medical Monitor

Role & responsibilities

• Associate Research Physician in clinical trial related projects covers various therapeutic areas, medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation and in accordance with applicable regulatory and SOP requirements.
• Support in the preparation and review of protocol related appendices like Investigators Brochure, Informed Consent Document, Investigators Undertaking, and any other documents related to protocol and CSR.
• Review of the MedDRA and WHO Drug Insight coding as and when required for the projects.
• Support the Senior Research Physician in generating SAE narratives and performing quality review and analysis of similar events.
• Communication of the SAE to all stakeholders as per the format and timelines indicated in the guidelines and internal SOP and keep a track of the same when required for clinical trials.
• Take a lead role in drafting the Integrated Summary of Safety and Efficacy for all clinical trial projects where in he/she is designated the responsibility.
• Review of protocol and protocol synopsis for BA/BE and phase studies in collaboration with clinicians, bioanalytical personnel, biostatisticians, regulatory affairs personnel, and medical monitor.
• Preparation of Medical Monitoring Plan (MMP) and Risk Evaluation and Mitigation Strategy (REMS), if applicable.
• Preparation of SFQs (Site Feasibility Questionnaires) and summary for patient-based studies.
• Training the required study team members and addressing protocol related queries in a timely manner.
• Provide input regarding deliverables with accuracy timelines and processes and support completion of quality regulatory documents. Managing documents with multiple review cycles and deadlines