Medical Monitor (Gastroenterology)
Core
Advise clients, project teams, and regulatory agencies on medical matters to ensure the safety of study participants and compliance with protocols in clinical trials.
Role type
Medical Monitor (Gastroenterology)
Builds
Clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, and manuscripts.
Domain
Pharmaceutical industry / Clinical Research / Gastroenterology
Deliverable
client delivery
Required skills
Medical Doctor degree, Board-certification in Gastroenterology, Clinical experience in major therapeutic areas (Oncology, Infectious disease, Gastroenterology, Hematology, Internal Medicine), Prior experience in Clinical Research, Familiarity with local regulations regarding clinical research trials, Ability to interact with and train clinical monitors and physician investigators, Proficiency with MS Office applications
Preferred skills
Experience with local health authority interactions leading to drug approval, Ability to organize and lead clinical development advisory boards and safety monitoring boards
Technologies
MS Office applications
Responsibilities
Review and analysis of clinical data to ensure the safety of study participants, Ensure reported data is accurate, complete, and verifiable, Address safety issues across the study from sites and the study team, Participate in bid defense meetings, Assist in Pharmacovigilance activities, Identify Program risks and create mitigation strategies, Ensure Study team compliance with local regulatory agencies, ICH and GCP guidelines, Review and sign off clinical documents with respect to medical relevance
Seniority
Mid-level, hands-on IC
