Medical Monitor (Gastroenterologist)
Core
Provide medical input to global clinical studies, ensuring patient safety and advising teams on medical and safety matters.
Role type
Senior Medical Monitor (Gastroenterologist)
Builds
Global clinical trials for pharmaceutical clients
Domain
Clinical Research / Gastroenterology
Required skills
Medical Doctor degree, 10+ years practicing Gastroenterologist experience, Clinical Research experience, English (fluent), Portuguese (fluent), MS Office proficiency
Preferred skills
Clinical Research experience
Technologies
MS Office
Responsibilities
Act as primary point of contact for trial-specific medical and safety questions; Provide input for responses to regulatory authorities and IRBs/IECs; Monitor trial participant safety; Participate in recruitment boost and retention activities; Present on medical matters at kick-off and investigator meetings; Train trial team in therapeutic area and protocol medical aspects; Develop and review trial-specific documents; Manage ongoing trial risks related to medical monitoring; Perform ongoing medical review of operational clinical trial database; Review protocol deviations; Review RAE reports, write/review SAE narratives, support Pharmacovigilance team; Review IND/SUSAR Safety Reports and annual IND reports; Participate in management of trial-related committees (IDMC/adjudication); Support Pharmacovigilance, Medical Data Review, and Data Management; Review clinical study reports (CSRs); Provide medical expertise on an as-needed basis; Prepare for and participate in trial audits; Participate in feasibility assessment of potential and ongoing trials; Participate in bid defense meetings; Act as medical expert providing therapeutic expertise to other departments.