Syllabus
Clinical Trial Project Management Professional Certificate
40 lessons, about 14 hours. Online and self-paced, with a certificate when you finish.
Project Foundations and Governance
Establish the regulatory accountability, governance, decision-making, and integrated planning foundations required to manage a clinical trial from initiation through completion.
- 1Clinical Trial Lifecycle and Management Roles
- 2Regulatory Accountability and Study Responsibilities
- 3Clinical Trial Project Charter Development
- 4Study Governance and Decision Rights
- 5Work Breakdown and Integrated Study Planning
Feasibility and Study Startup
Evaluate protocol feasibility and develop defensible study timelines, regulatory dependencies, site activation strategies, and participant enrollment forecasts.
- 6Protocol Feasibility and Quality by Design
- 7Regulatory Dependencies and Investigator Qualification
- 8IRB Oversight and Informed Consent Operations
- 9Integrated Study Timeline and Activation
- 10Enrollment Forecasting and Recruitment Modeling
- 11Participant Retention and Decentralized Trials
Study Budget and Financial Control
Build comprehensive clinical trial budgets, forecast expenditures, manage site financial arrangements, and maintain financial control throughout the study lifecycle.
- 12Clinical Trial Budget Structure and Costing
- 13Participant Costs and Financial Scenarios
- 14Study Cash Flow and Financial Forecasting
- 15Budget Variance and Cost Recovery
- 16Site Contracts and Budget Negotiation
CRO and Vendor Management
Develop a risk-proportionate vendor strategy, establish enforceable operational expectations, manage written responsibility transfers, and oversee outsourced clinical trial performance.
- 17CRO and Vendor Qualification
- 18Vendor Technology and Data Governance
- 19CRO Agreements and Written Responsibility Transfers
- 20Vendor KPIs and Service-Level Agreements
- 21Vendor Governance and Remediation
Risk, Quality and Regulatory Oversight
Apply clinical quality management and regulatory accountability principles to study risk identification, monitoring, safety escalation, issue resolution, and sponsor oversight.
- 22Critical-to-Quality Risk Assessment
- 23Study Risk Register and Mitigation Plans
- 24Issue Management and Escalation Pathways
- 25IND Safety Reporting and Corrective Actions
- 26Investigator Safety Reports, Essential Records and Regulatory Documentation
- 27Risk-Based Monitoring and Quality Management
- 28Centralized Monitoring and Quality Dashboards
Study Execution and Performance
Lead cross-functional study teams, monitor performance against integrated baselines, coordinate regulatory and operational changes, and recover studies from execution problems.
- 29Clinical Trial Team Leadership and Meetings
- 30Cross-Functional Safety and Issue Coordination
- 31Study Dashboards and KPI Reporting
- 32Leadership Reporting and Study Forecasting
- 33Operational Problem Solving and Recovery
- 34Protocol Amendments and Controlled Changes
Closeout and Database Lock
Coordinate study and site closeout, reconcile clinical data and investigational products, achieve documented database lock readiness, complete reporting obligations, and evaluate final project performance.
- 35Site Closeout and Study Completion
- 36Investigational Product and Essential Record Reconciliation
- 37Clinical Data Cleaning and Reconciliation
- 38Database Lock Readiness and Authorization
- 39Essential Records and ClinicalTrials.gov Reporting
- 40Final Study Evaluation and Lessons Learned