New
SM
Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Clinical Trial Project Management Course & Certification
Intermediate
4.7
★★★★★
97% Recommended
Updated 2026
3 hours
88 active users
3 points
Your Study Basket
1 x Clinical Trial Project Management
| Total |
VAT is levied as per your country’s applicable rules and rates at checkout
Save more with a monthly or annual plan that includes this course
Secure Payment Service
Rest assured we use secure processes to protect your payment.
Secured by:
About
The Clinical Trial Project Management Course is designed to provide a comprehensive understanding of planning, executing, and overseeing clinical trials across all phases of drug development. It focuses on the role of the Clinical Trial Project Manager in ensuring that studies are delivered on time, within budget, and in compliance with regulatory, ethical, and quality standards.
This course covers key aspects of clinical trial management, including study planning, timeline and budget management, cross-functional team coordination, risk management, vendor and CRO oversight, communication strategies, and regulatory compliance. It also emphasizes quality-driven project execution, stakeholder management, and inspection readiness throughout the clinical trial lifecycle. Upon completion, learners will receive a certification demonstrating their competence in managing clinical trial operations effectively.
Who Should Enrol?
- Clinical Trial Project Managers and Study Managers
- Clinical Research Associates (CRAs)
- Clinical Trial Coordinators and Clinical Operations Professionals
- Clinical Trial Assistants (CTAs)
- Pharmaceutical and Biotechnology Professionals
- CRO Project Management and Operations Teams
- Regulatory Affairs and Quality Assurance Personnel
- Medical and Life Science Graduates entering clinical operations
- Professionals transitioning into clinical trial project management
- Anyone involved in planning, coordinating, or managing clinical research projects
What you will learn
Understand the fundamentals of clinical trial project management, including trial phases, stakeholders, regulatory pathways, and study design principles.
Learn project planning and execution skills such as scope definition, timelines, budgeting, resource allocation, and risk-based quality management.
Gain knowledge of vendor and site management, including CRO selection, contracting, communication strategies, recruitment, retention, and operational oversight.
Develop competence in trial tracking and close-out activities, including performance monitoring, issue management, database lock, reporting, and archiving for regulatory compliance.
Course Syllabus
- Overview of clinical trial phases, stakeholders, and regulatory landscape
- Covers study design elements (endpoints, randomization, blinding, statistical considerations) and the regulatory submission process (IND/CTA filing, ethics submissions)
- Teaches standard PM techniques as applied to trials: defining scope, milestones, and deliverables; creating Work Breakdown Structures and project schedules (Gantt charts, critical path analysis)
- Focuses on clinical trial costing, budget development, and financial monitoring
- Introduces quality management systems and risk-based approaches (per ICH E6(R3) and E8(R1))[15]
- Covers outsourcing strategy: selecting CROs and other service providers, creating quality agreements, and contract management
- Emphasizes interpersonal skills and team coordination
- Addresses operational execution: site selection/activation, patient recruitment strategies, retention tactics, and site oversight
- Focuses on ongoing control of the trial: using metrics, dashboards, and status reports
- Covers steps to end a trial and hand over for analysis: database lock, final monitoring, regulatory reports, archives
Our Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
Frequently Asked Questions
The Clinical Trial Project Management Course by Whitehall Training provides a comprehensive foundation for professionals and combines standard project management methods with the specialized context of clinical research.
- The fundamentals of clinical research and trial phases and core responsibilities and day-to-day tasks of a CRA
- Key ICH GCP E6(R3) principles and regulatory expectations
- How to prepare for and conduct monitoring visits
- Risk-based and remote monitoring approaches
- Investigational Product (IP) oversight and accountability
- Safety reporting requirements (AE/SAE/SUSAR)
- Site communication, documentation, and issue escalation
- Close-out procedures and essential record archiving
This course is ideal for individuals who want to begin or advance a career in clinical research, including:
- Aspiring Clinical Research Associates (CRAs)
- Clinical trial site staff transitioning into monitoring roles
- Clinical Research Coordinators (CRCs) seeking career progression
- Professionals working in pharmaceutical, biotech, or CRO environments
- Anyone seeking a strong foundation in monitoring, GCP, and site oversight .
- Industry-aligned CPM training with global recognition
- Fully updated to ICH GCP E6 (R3) requirements
- Ideal for aspiring CPMs and those transitioning from site roles
- Practical, scenario-based learning to build real-world confidence
- Certificate issued upon successful completion
Best Seller
