Medical Monitor (Gastroenterology)
Core
Medical professional advising clients and project teams on medical matters, ensuring study safety and compliance, and reviewing clinical documents for gastroenterology 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
Medical Doctor degree, review and analysis of clinical data, ensure data accuracy and compliance with protocol, address safety issues, organize and lead clinical development advisory boards and safety monitoring boards, ensure compliance with local regulatory agencies, ICH and GCP guidelines, review and sign off clinical documents
Preferred skills
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 and health authority interactions, ability to interact with and train clinical monitors and physician investigators
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 different scientific presentations; Review and analysis of clinical data to ensure the safety of study participants in clinical studies; Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments; 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 and implement mitigation strategies with Clinical Operations; Ability to organise 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
