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 verifiability, address safety issues across studies, identify program risks and implement 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
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 clinical concepts, practices, and local regulations regarding clinical research trials, 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
