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As clinical trials become more complex and there is increasing demand for efficiency and cost effectiveness, the knowledge and skills required to manage all aspects of a clinical project are critical.

This course provides a comprehensive foundation in clinical project management. Using the Project Management Body of Knowledge (PMBOK®) as a guide, participants will be taught how to apply project management strategies, tools and techniques to their clinical trial projects.

In two independent modules of three days each, the following topics will be covered:

  • Project Definition and Organisational Context
  • Project Management Tools and Techniques
  • Scope Management, Resource Estimating and Budget Management of a Clinical Trial
  • Project Quality Management
  • Project Risk Management
  • Communication and Stakeholder Management
  • Procurement Management
  • Team Management and Leadership Skills

This course includes many practical examples and case studies which will enable participants to successfully implement and manage their own clinical trial projects effectively.

The course is based on Alexander Gissler’s (PMP, Project Management Consultancy and Training) concept for Clinical Project Management.

Participants are requested to bring their own laptops for this hands-on course. Software required: MS Excel 2007 or later, Open Project (free software available from

Part I - Key Topics

  • Project Definition and Organisational Context
  • Project Management Strategies, Techniques and Tools
  • Defining the Scope of a Project
  • Resourcing and Scheduling
  • Budgeting and Controlling

Part II - Key Topics (currently scheduled from 10-12 Novemebr 2014 in Barcelona, Spain)

  • Quality Management
  • Procurement Management
  • Leadership Skills
  • Project Team Management
  • Communication and Stakeholder Management
  • Risk Management
  • Lessons Learned

Who should attend?

This training course is geared toward professionals who desire a comprehensive foundation in clinical project management. Participants should have at least two years of clinical trial experience, or have completed the DIA training course “Essentials of Clinical Study Management.”

This "Clinical Project Management" training course is targeted at an intermediate/advanced level.

Continuing Education

The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this training course with 19 credits.

Learning objectives

Part I - Learning Objectives

At the conclusion of this course, participants should be able to:

  • Define a project, and differences in organisational structures as well as their impact on leading a clinical trial
  • Identify the processes required to successfully plan, execute, monitor and control as well as close-out a complex clinical trial
  • Define, plan, manage and verify the scope of a clinical trial, estimate the resource needs and sequencing activities to produce a project schedule (Network Diagram and Gantt Chart)
  • Estimate and control budgets for clinical trials

Part II - Learning Objectives

At the conclusion of this course, participants should be able to:

  • Efficiently plan and manage the quality of a complex clinical trial
  • Develop the skills to successfully handle external resources and acquire trial material
  • Develop different soft skills required to be a great clinical study manager, e.g. negotiation skills, leadership without authority, motivational skills, etc
  • Plan and execute formal and informal communication, including reporting. Identify and manage stakeholders, including reporting to stakeholders
  • Identify risks, estimate their probability, determine their impact, plan contingencies and quantify the budgetary requirements for these contingencies
  • Plan and manage recording of lessons learned to improve best clinical trial management practice within your organisation and/or globally


Contact us

DIA Europe
Kuechengasse 16
4051 Basel

Tel.: +41 61 225 51 51
Fax: +41 61 225 51 52