The Basics of Project Management for Sr CRAs and Jr PMs

Description
Operational

If you are a senior CRA or junior Project Manager and want to get prepared for Project Management work or increase your Project Management insights, then this course is waiting for you.

This training is a full-day course to cover all the basic aspects of clinical project management based on real-life examples.

At the end, you will receive a certificate and the course hand-outs.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Define PM in clinical research and related responsibilities
  • Draft project plans and scope of work
  • Draft project specific guidance and controlled documents such as safety management plan, communication plan, risk management plan, TMF checklists, DPIA templates, monitoring plan, quality plan
  • Draft metrics for projects to monitor and control project deliverables
  • Establish project oversight
  • Ensure SOP compliance
  • Make sure of a lean and compliant project closure and termination of contract obligations
  • Be responsible for the various project phases of start-up, initiation, execution, monitoring and close out
  • Manage the study budget on a basic level
  • • Ensure efficient communication with vendors
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Gerald Van Roey
Gerald Van Roey MPhEd had over 10 years of experience in Clinical Operations before switching his career into the training business in 2009. He has worked as trainer and managing director for the ECCRT, European Centre for Clinical Research Training before starting his own company in 2015. As a clinical monitor he performed more than 40 studies in areas including pharmaceutical, biotechnology and medical devices in all stages of clinical development. In his previous career he implemented different trial tools and mentored many junior CRAs. His extensive knowledge and background serves him as a manager and trainer for different courses. In his trainer function he has coached over 1000 clinical research professionals and has delivered courses in 14 different countries.