· Provide medical leadership for clinical trials from protocol development through clinical study report completion
· Develop and review medical content within Clinical Trial Protocols and contribute to protocol updates as needed
· Contribute to risk-based quality management by identifying medically relevant critical data, risks, and mitigation strategies
· Provide medical input into Clinical Quality Monitoring Plans, important protocol deviation assessments, and clinical quality activities
· Perform ongoing medical review of aggregated clinical trial data, identify risks and quality issues, and support timely mitigation and escalation activities
· Contribute medical expertise to key study documents including eCRF design, Data Review Plans, informed consent documents, monitoring manuals, communication plans, training plans, and statistical analysis plans
· Support preparation of patient narratives and review medical content of Clinical Trial Reports
· Respond to medical questions from investigators, CRO partners, and sponsor representatives while maintaining high standards of medical expertise
· Provide medical input into study feasibility, patient recruitment, retention strategies, and site engagement activities
· Support interactions with Ethics Committees, Institutional Review Boards, Data Monitoring Committees, Data Safety Monitoring Boards, Steering Committees, and regulatory authorities as applicable
· Deliver medical training for investigators, study teams, and sponsor personnel
· Contribute to trial communications, newsletters, and scientific publications where applicable