NoyMed Academy Certified Clinical Trial Manager
Run a clinical trial end to end - timelines, budget, vendors, sites, and risk.
About this program
For CRAs and coordinators stepping up to operational leadership of a study or program.
Who it is for
Senior CRAs, lead coordinators, and operations staff moving into trial management.
Prerequisites
- Two or more years in clinical operations
- Working knowledge of ICH-GCP
- Exposure to study timelines and budgets
Curriculum outline
1. Study start-up
From protocol to first patient in.
Topics: Timeline construction · Country and site strategy · Regulatory and ethics submissions · Vendor selection
2. Operational oversight
Keeping a study on track.
Topics: Enrollment management · Metrics and KPIs · Issue escalation · Monitoring oversight
3. Budget and vendors
Managing cost and third parties.
Topics: Budget tracking · Change orders · CRO and vendor governance · Invoicing
4. Risk and quality
Risk-based quality management.
Topics: Risk assessment (RACT) · Quality tolerance limits · Inspection readiness
5. Close-out and lessons learned
Completing and reflecting.
Topics: Database lock coordination · TMF reconciliation · Retrospective
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