This is a 2-day course designed to introduce the ins and outs of managing clinical research projects. The clinical study setting allows you to implement this knowledge immediately within your research projects.
During these 2-days, you will learn the basics of project management adapted to clinical trials. You will see how to manage clinical trials, setting milestones, doing risk management, allocating staff and budgets, dealing with clients and contracts. Several components of successful project management such as interaction between project activities and key decisions will be highlighted.
This is a very interactive course with a lot of workshops, putting the theoretical concepts into practice.
Course time09h00 - 17h00
Who should attend
- Project managers (or related clinical research professionals) who have just entered the world of project management in clinical research. For Project managers with experience, we offer our Advanced PM course.
- Senior Clinical Research Associates (CRAs) who want to set new goals for their career as clinical research project team leaders.
- Prior experience in and/or knowledge of ICH-GCP and Clinical Research is required (at least 2 years in the field)
- What are the fundamentals of Project Management?
- What is a Project?
- What is a Project Manager (skills, techniques)?
- The Project Manager (negotiation, delegation, dealing with clients, quality)?
- What are the Project Management Methodologies?
- The Project Environment (regulations, guidelines, SOPs)
- Clinical Trial life cycle, an overview
- The definition and initiation of a Trial (scope, feasibility, charter)
- The planning of the Trial (project plan, milestones, schedules, charts, risk management, contracts)
- The Project Budget (budget sheets, budget control)
- The execution of the Trial (monitoring and controlling, reporting, dealing with changes, team management)
- The closure of the Trial (archiving, evaluation, project failure reasons).
- Know the fundamentals of clinical research project management
- Understand the theory and application of key issues in design, management and closure of clinical research projects
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (1)
- Investigational Product Development and Regulation (0)
- Clinical Studies Operations (GCPs or ISO 14155) (5)
- Study and Site Management (8)
- Data Management and Informatics (2)
- Leadership and Professionalism (4)
- Communication (4)
- Teamwork (3)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained