Central Review Manager (CRM)
Core
Perform centralized review and approval of clinical monitoring visit reports (PSA, SI IMV, CO) to ensure protocol consistency, site safety, and regulatory compliance across global projects.
Role type
Central Review Manager (Clinical Research)
Builds
Centralized review outputs for clinical monitoring visits supporting pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Required skills
Clinical monitoring report review, Protocol adherence assessment, Site safety evaluation, Regulatory guideline knowledge (FDA, ICH GCP), Data extraction from CTMS/electronic systems, Risk assessment at site level, Forecast estimation, Audit response support
Preferred skills
Therapeutic area knowledge, Medical terminology, Mentorship of junior staff
Technologies
CTMS, Electronic study data systems, Monitoring Report Templates
Responsibilities
Review and approve clinical monitoring visit reports for allocated projects, Liaise with clinical monitoring staff for timely report submission, Customize monitoring report templates, Evaluate PI oversight and subject safety, Attend internal project meetings, Provide forecast estimates for review activities, Track trial MVR status and progress, Contribute to regulatory audit responses