Medical Monitor (US Board-Certified Gastroenterologist)
Core
Provides medical input to global clinical studies, advises teams on patient safety, and monitors trial participant safety.
Role type
Senior Medical Monitor (Gastroenterology)
Builds
Global clinical trials for pharmaceutical sponsors
Domain
Clinical Research / Gastroenterology
Required skills
US Board Certification in Gastroenterology, 10+ years practicing Gastroenterology experience, Medical Doctor degree, Clinical trial safety monitoring, Regulatory authority communication, IRB/IEC interaction, Protocol deviation review, Safety narrative writing, Clinical study report review, Audit preparation, Therapeutic area expertise
Preferred skills
Clinical Research experience, MS Office proficiency
Technologies
MS Office
Responsibilities
Acts as primary point of contact for medical and safety questions, Provides input for regulatory and IRB responses, Monitors trial participant safety, Participates in recruitment and retention, Presents at investigator meetings, Trains trial teams, Develops trial documents, Manages trial risks, Reviews clinical databases and protocol deviations, Writes SAE narratives, Supports Pharmacovigilance, Participates in data monitoring committees, Reviews clinical study reports, Prepares for audits, Assesses trial feasibility
Seniority
Senior, hands-on IC
