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Course Details

Course Title

Clinical Trials Project Management

Course Format

One or two day classroom course with a mix of presentations and workshop sessions

Learning Objectives

Everyone manages projects of some description and at the same time are also managed by others while working on a project. These projects can range from an entire clinical trial through to a component, or sub-project, of a trial, e.g. the identification and set-up of investigational sites in a specific country. In order to effectively manage the project it is essential to understand how to plan, track, manage and change a project to ensure the ultimate delivery of a quality product. By the end of the course the participants will be able to:

  • Identify the components of projects
  • Use planning methods to determine a project plan
  • Identify the critical path
  • Track the project, update the project and forecast future tasks
  • Implement risk, opportunity and change management
  • Understand quality and set quality targets for projects
Who is it for?

The course has previously been delivered for groups including:

  • CRAs, CTAs and Project Managers
  • Clinical Trials Supplies Staff
  • Medical Advisers
  • Data Managers
Course Content


  • Components of project and subprojects
  • Milestones, tasks, deliverables
  • PERT & Gantt
  • Critical Path Analysis
  • Stakeholder analysis

Risk, Opportunity and Change 

  • Identifying risk
  • Risk Log
  • Change management
  • Change management log

Project Tracking 

  • What to track
  • How to track
  • Variance analysis
  • Dealing with variance

Project Structure 

  • Critical Success Factors
  • Setting objectives
  • Responsibility matrix
  • Managing a Team
  • Communication

Ensuring Quality 

  • What is quality
  • QA, TQM, QC
  • Quality Objectives & Metrics
  • Project consistency

Motivation and Leadership 

  • Motivation theories
  • Leadership styles
  • Managing a cross functional team
  • Team styles
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