Clinical Operations
- Clinical Trial Protocol Design & Development
- CRO Selection
- Negotiation of Contracts between Sponsor and CRO
- Clinical Trial Site Selection
- Clinical Trial Management
- Clinical Project Management
- Safety Monitoring Committee (Safety Review Board)
- Risk Management
- Clinical Audit Inspection Readiness
- Clinical Quality Audits
- Management of Quality Events
- Root Cause Determination & CAPA
- Medical Monitoring
- Supplier Oversight & Auditing
- Management of Site Performance
- Data Management
- Statistical Analysis Plans
- Statistical Analysis Software (SAS) Programming
- Clinical Operations Quality Management System Development
- Good Clinical Practice (GCP) Training
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