Central Review Manager (Senior)
Core
Perform centralized review and approval of clinical monitoring visit reports (PSA, SI, ME, CO) to ensure protocol adherence, subject safety, and study process compliance.
Role type
Senior Central Review Manager (Clinical Operations)
Builds
Clinical trial monitoring reports and compliance assessments for pharmaceutical and biotech clients
Domain
Clinical Research / Pharmaceutical
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical monitoring report review, Protocol adherence assessment, Site safety evaluation, Regulatory guideline knowledge (FDA/ICH GCP), Clinical monitoring visit report writing, Risk assessment at site level, Forecast estimation for review activities, Trial MER status tracking, Training and mentoring junior staff
Preferred skills
Therapeutic area knowledge, Medical terminology expertise, Electronic study data systems proficiency, CTMS usage
Technologies
CTMS, Electronic study data systems
Responsibilities
Review and approve clinical monitoring visit reports for assigned projects; Liaise with clinical monitoring staff for timely report submission; Customize monitoring report templates; Evaluate PI oversight and subject safety; Provide input on forecast estimates for review activities; Track trial MER status and provide progress updates; Contribute to regulatory audit responses; Train and mentor new Central Review Managers.
Seniority
Senior, hands-on IC