Certified Australia Clinical Trials Project Manager (CCT™)
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43 Modules
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Live Executive Programs
This certified program will equip you to master clinical trial regulations, apply ICH-GCP standards, and lead compliant, ethical, and high-quality clinical research across Australia.
Key skills you will gain:
- TGA CTN/CTX Mastery
- Multi-HREC Submission Management
- Ethics Review Navigation
- ICH-GCP E6(R2/R3) Compliance
- Risk-Based Monitoring (RBM)
- Quality-By-Design (QbD) Application
- Risk-Based Quality Management (RBQM)
- Critical Data Identification
- Protocol Feasibility Assessment
- Trial Budgeting Excellence
- Site Selection Strategy
- Contract & CTA Negotiation
- Vendor & CRO Oversight
- Recruitment & Retention Planning
- Informed Consent Management
- Adverse Event Reporting
- Safety Data Reconciliation
- TMF Management & Integrity
- Audit & Inspection Readiness
- CAPA Development Skills
- Data Integrity (ALCOA+) Compliance
- Remote & Hybrid Monitoring
- KPI-Driven Performance Oversight
- Cross-Functional Team Coordination
- Monitoring Plan Development
- Protocol Deviation Management
- Project Timeline Optimization
- Clinical Study Report (CSR) Integration
- Stakeholder Communication Strategy
- End-Of-Trial Regulatory Notification Skills