Medical Monitor (Gastroenterology)
Core
Advise clients and project teams on medical matters, review clinical data for safety, and ensure trial compliance with protocols and regulations.
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
Medical Doctor degree, review and analysis of clinical data, ensure data accuracy and compliance, address safety issues, organize and lead clinical development advisory boards, review and sign off clinical documents
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 for drug approval
Technologies
MS Office applications
Responsibilities
Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies, and third-party vendors on medical matters; Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations; 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; Participate in bid defense meetings; Assist in Pharmacovigilance activities; Identify Program risks and create mitigation strategies; Organize and lead clinical development advisory boards and safety monitoring boards; 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
