Medical Monitor, Rheumatology, Canada or Argentina
Core
Provides medical and scientific support to clinical research programs in rheumatology, ensuring data integrity and subject safety oversight.
Role type
Medical Monitor (Clinical Research)
Builds
Clinical research programs for dermatology/biopharmaceutical clients
Domain
Clinical Research / Rheumatology
Required skills
Medical degree, Rheumatology expertise, Clinical research protocol knowledge, Safety data review, SAE reporting, Protocol deviation assessment, Investigator communication, Data trend analysis
Preferred skills
Drug development process knowledge, GCP knowledge, Multidisciplinary collaboration, Independent work
Technologies
Clinical trial management systems, Safety databases, Coding listings
Responsibilities
Review subject safety-related data listings to identify trends and unreported protocol deviations; Provide medical review of SAE forms and write SAE narratives; Advise sites on protocol inclusion/exclusion criteria and concomitant medications; Assess impact of prohibited medications on study subjects; Participate in central monitoring activities for safety signal detection; Serve as non-voting member of safety committee; Provide 24/7 on-call service for urgent safety matters.
Seniority
Mid-level, hands-on IC