Medical Monitor (Gastroenterologist)

Conduct primary medical monitoring for global clinical trials by acting as the point of contact for safety and medical questions, reviewing protocol deviations, and managing trial risks. Monitor participant safety, prepare responses for regulatory authorities and IRBs, and review clinical study reports including safety narratives. Train the trial team on protocol medical aspects, present at investigator meetings, and support pharmacovigilance with safety queries and database reconciliation. Participate in audit follow-ups, data monitoring committee management, and feasibility assessments for ongoing trials. Provide therapeutic expertise to other PSI departments and support bid defense meetings.