Training Course on Clinical Project Management - Part I

Date(s) And Time(s):
Oct 5 2011 8:00AM - Oct 7 2011 4:00PM

Hotel Mercure Vienna Europaplatz
Matrosengasse 6-8
1060 Vienna


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.

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

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

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

Target Audience:

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.

Event Code:

Contact Information:

DIA Europe
4002 BASEL
TEL.: +41 61 22 55 151
FAX: +41 61 22 55 152