Project Management for Clinical Trials

Efficient and well-structured project management is the basis for a successful clinical trial.

The first two days of this seminar provide a thorough and comprehensive insight into the tasks and responsibilities of a Project Manager in clinical research. In addition to learning what a Project Manager does during the various stages of a trial, participants will gain practical tips they can apply in the workplace and useful information about organization, time management and communication strategies, essential for a successful career in project management.

The third day consists of an optional practical workshop. This may be booked additionally. It provides participants with the opportunity to gain first-hand experience in applying project management tools to practical examples and case studies, deepening participants’ understanding, and ensuring lasting results.

This seminar is aimed at professionals and managers working in clinical research and medical affairs departments in CROs or the pharmaceutical industry.

It is particularly suitable for:

• Project Managers / Project Leaders
• Clinical Monitors / CRA
• Study Coordinators
• Medical Managers

On completion of this very practical course you will appreciate the pivotal role of a Project Manager in clinical trials. You will recognize the importance of being able to lead and motivate a team, and of possessing excellent time management, communication and negotiation skills.

You will understand the project life-cycle and the need for contingency planning. You will obtain insight into how study costs are calculated, and learn about capacity planning, budgeting and the monitoring of large international projects.

You will learn how to how to set milestones, analyze risk, and practice these skills using realistic scenarios and standard project planning and decision making tools.

The Project

• Project definition
• Project/program/portfolio

The Project Manager

• Roles and responsibilities in clinical trials
• The ‘ideal’ Project Manager
  • Factors for success
• Personal pre-requisites
• Knowledge, skills and competence

The Project Team

• Organizing a team
• Decision making levels and powers of authority
• Delegation and distribution of tasks
• Responsibilities and levels of decision making
• ‘Good communication practice’
  • Channels of communication and information flow in teams
• Meeting culture
• Conflict management
• The goal: a successful and effective project team

Project Planning

• Project life-cycle
• The magic triangle: variables under control
• Defining the scope and limits of a project
• Project planning
  • Clinical Trial Operations Plan
  • Project Management Plan
• Establishing a timeline, setting milestones
• Efficient project management tools
  • Planning with MS Project and Excel
  • Simulations
• Recruitment planning and strategies
  • Site and investigator selection
• Risk management: The contingency plan
  • Contents
  • Potentials risk areas/ risk categories

Preparation and Conduct of a Clinical Trial

• Developing the protocol
• Contact with Ethics Committees and Responsible Authorities
• Metrics and analyses as aids for project assessment
  • Allocation and sources of metrics
  • Validating measuring instruments
  • Interpreting data
• Analyzing problems and assessing their severity
  • Setting priorities
  • Decision making tools
  • Risk assessment and quality management
• Reporting
  • Static, analytical or interactive reporting?
  • Software models and their practicability
• Documentation and archiving

Capacity and Budget Planning and Control

• Optimum planning of resources
  • Study complexity
  • Utilization and experience of CRA
• Budget control
  • Levels of budget planning
  • Calculating the budget
  • Typical problems
• Capacity and budget planning in international projects
• Budget and manpower planning
  • Calculating study costs
  • Monitoring Plan
  • Acceptable tolerance limits in the event of deviation

By means of practical examples and case studies, participants will be able to practice using various project management tools under the guidance of experienced professionals.

Case Study: From the Planning to the Monitoring of a Clinical Trial

• Brainstorming at the start of a project
  • Using mind-mapping to collect and structure ideas
• Drawing up the budget
  • What costs need to be included?
  • How much of a buffer is necessary?
  • Where is there scope for meaningful cost savings?
• Creating the clinical trial operation plan
  • What needs to be considered and what has priority?
  • What are the timelines?
  • What are the strategies for recruitment and what is the time plan for the trial?
  • Who is responsible for what and when?
  • Communication flow
• Capacity planning
  • How much manpower is required for individual parts of the trial and work processes?
  • At what point must workforce capacity be ready?
  • What can be done to compensate for outage?
• Quantitative decision making models and project control
  • Monitoring recruitment – planned vs. actual numbers
  • Can timelines be maintained or is there a danger of delay?
  • What needs to be done in the event of deviation from plan?
  • What are the consequences?
  • What measures need to be taken?

William Fu
Director Parexel Academy, APAC

Phone: +86 21 5106 4306

Email: Send email