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

The course has previously been delivered for groups including:

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

Projects

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

Risk, Opportunity and Change 

• Definition of what risk means in project management
• Identifying risk in clinical trial project management
• 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 of a Trial
• Setting objectives
• Responsibility matrix
• Managing a Project Team
• Communication

Ensuring Quality 

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

Motivation and Leadership 

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