Management Courses
Part of a STAR Programme

This is a two 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.

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 time
09h00 - 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 Clinical Research is required (at least 2 years in the field)
Programme highlights
  • 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)
Learning Objectives
  • Know the fundamentals of clinical research project managements
  • Understand the theory and application of key issues in design, management and closure of clinical research projects

Book a course

Date Lang Location
Proceeding your application may take up to 24 working hours. In case of question, contact
1 500,00 € excl. VAT (if applicable)


Kristy Fickinger
September 2018


I learnt about
  • the clinical trial cycle, abbreviations related to pharmaceuticals (given I come from medical device industry this was new), and budgeting / timesheets / forecasting - Same agenda / timeframe of closeout meeting.
  • Strategies for moderating effective Lessons Learned meetings
  • Unanticipated trial closure procedure (e.g. study stopped for unethical reasons, unblinding procedure, extent to which CPM is involved)
  • Division of tasks that CPM should NOT do
Small group size - Interactive style.
Finally, all the questions were answered and the Trainer constantly clarified understanding of abbreviations, so you never felt silly to ask.