How to ensure a successful clinical trial within timelines and budget?
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.
What is a Project?
What are the fundamentals of Project Management?
What is a Project Manager (skills and techniques such as negotiation, delegation, dealing with clients and quality)?
What are the Project Management Methodologies?
The Project Environment (regulations, guidelines, SOPs)
The 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
Discover the steps and tools to become an efficient project manager
Who should attend
Project managers (or related clinical research professionals) who have just entered this position in clinical operations. 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 GCP and Clinical Research is required (at least 2 years in the field)
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