Medical Monitor (Gastroenterologist)
Core
Provides medical input to global clinical studies, focusing on patient safety and well-being while advising teams and business partners.
Role type
Senior Medical Monitor (Gastroenterologist)
Builds
Global clinical studies for pharmaceutical clients
Domain
Clinical Research / Gastroenterology
Required skills
Medical Doctor degree, 10+ years practicing Gastroenterology experience, Clinical Research experience, MS Office proficiency, Analytical skills, Problem-solving
Preferred skills
Clinical Research experience, Communication skills, Presentation skills, Teamwork, Detail-oriented
Technologies
MS Office
Responsibilities
Acts as primary point of contact for medical and safety questions; Provides input for regulatory and IRB/IEC responses; Monitors trial participant safety; Participates in recruitment and retention; Presents at kick-off and investigator meetings; Trains trial teams; Develops and reviews trial documents; Manages trial risks; Performs medical review of trial databases; Reviews protocol deviations and safety reports (RAE, SAE, IND/SUSAR); Participates in trial committees; Supports Pharmacovigilance and data management; Reviews clinical study reports; Prepares for audits; Assesses trial feasibility; Participates in bid defense meetings.
Seniority
Senior, hands-on IC