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, manuscripts, and scientific presentations
Domain
Pharmaceutical industry / Clinical Research / Gastroenterology
Deliverable
client delivery
Required skills
Review and analysis of clinical data, ensure data accuracy and compliance with ICH/GCP guidelines, address safety issues across studies, organize and lead clinical development advisory boards, review and sign off clinical documents, identify program risks and implement mitigation strategies
Preferred skills
Board-certification in Gastroenterology, clinical experience in Oncology, Infectious disease, Hematology, or Internal Medicine, prior experience in Clinical Research, familiarity with local health authority interactions leading to drug approval
Technologies
MS Office applications
Responsibilities
Advise clients and project teams on medical matters, collaborate on clinical development plans and protocols, review clinical data for participant safety, ensure trial compliance with approved protocols, address safety issues, participate in bid defense meetings, assist in Pharmacovigilance activities, lead clinical development advisory boards, ensure study team compliance with regulations, review and sign off clinical documents
Seniority
Mid-to-Senior level, requires ability to lead boards and work with minimal guidance
