Medical Monitor (Gastroenterologist)
Core
Provide medical input to global clinical studies, ensuring patient safety and advising teams on medical and safety matters.
Role type
Senior Medical Monitor (Gastroenterologist)
Builds
Global clinical trials for pharmaceutical clients
Domain
Clinical Research / Gastroenterology
Deliverable
client delivery
Required skills
Medical monitoring, safety monitoring, protocol deviation review, SAE narrative writing, regulatory authority interaction, IRB/IEC communication, clinical study report review, therapeutic expertise, risk management, audit preparation
Preferred skills
Clinical research experience, bid defense participation, feasibility assessment
Technologies
MS Office applications
Responsibilities
Act as primary point of contact for trial-specific medical and safety questions; provide input for regulatory and IRB responses; monitor participant safety; present at investigator meetings; train trial teams; review protocol deviations and safety reports; manage trial-related committees; support pharmacovigilance and data reconciliation; prepare for audits.
Seniority
Senior, hands-on IC
