Project Management in Clinical Study Operations

Clinical trials are highly complex enterprises that demand professional management at every stage and level. Project managers in clinical study operations take on many challenges including multiple stakeholders, budget control and stringent quality and regulatory requirements. This course teaches the general principles and theory of project management in the context of clinical study operations. In a workshop setting, participants will learn all essential tools for the successful planning, execution, monitoring and controlling of clinical study activities through highly interactive exercises and discussions.

Main topics are: stakeholder management, roles and responsibilities of the project manager and the team, Work Breakdown Structure, project schedule and time management, resource management, quality assurance and quality control, risk management strategies, communication processes.

Learning Objectives:

  • Define a project in the context of a clinical trial
  • Discuss the role and responsibilities of a project manager and how the role can change
  • Define a scope statement as the basis for further project planning, execution and/or monitoring and controlling activities
  • Conduct a stakeholder analysis, discuss what is needed to keep stakeholders aligned to support the project and develop reports to keep stakeholders informed
  • Organise the team’s work by developing and managing a Work Breakdown Structure (WBS)
  • Create and manage a project schedule
  • Define roles and responsibilities of team members, estimate the work efforts and discuss procurement options
  • Identify the roles and functions of quality assurance and quality control
  • Develop a project budget (forecast)
  • Address potential threads to a project and develop a risk management strategy and plan
  • Manage changes and anticipate how this impacts the schedule, quality, resources and budget
  • Discuss the communication process

3-day classroom training plus pre-reading and homework assignments.

Recommended for everyone working in clinical study operations (physicians, principal investigators, study nurses, study coordinators, study managers, study monitors etc.) in the academic field or a commercial setting wanting to gain proficiency in project management.

Basic knowledge and experience in operational clinical research is highly recommended. No previous knowledge in project management required.

  • Dr Daniel Hammes, Studiengangleitung
  • Dr. Annette Mollet, Studiengangleitung
  • Ingrid Klingmann, MD, PhD, Managing Director, Pharmaplex bvba, Wezembeek-Oppem, Belgium
  • Jennifer Kealy, MSc, Head of Clinical and Regulatory Affairs, FIND, Geneva, Switzerland

Daniel Hammes, PhD
Training and Education
Department of Clinical Research
University of Basel
c/o University Hospital Basel
Phone +41 61 328 54 16

Annette Mollet, PhD
Head of Training Institute of Pharmaceutica Medicine - ECPM
University of Basel
Klingelbergstrasse 61
CH-4056 Basel
Phone +41 61 207 19 52/50

CHF 1'500
Fee includes course materials and provision during coffee/tea breaks.

The Department of Clinical Research at the University of Basel supports members of registered clinical research groups by granting reduced course fees. If applicable, please provide the name of your clinical research group leader to be considered for a grant.

Cancellation of your registration is possible until 10 days before the course date. Cancellation thereafter or absence from the course will result in a cancelation fee of half the course fee.

Kurs beginnt am:
Dienstag, 30.06.2020
Kurs endet am:
Donnerstag, 02.07.2020

Medical Faculty of the University of Basel

The course language is English.
Certificate of attendance issued by the University of Basel, Advanced Studies: 2 ECTS


Hörsaal 5, Klinikum 1, Universitätsspital Basel Spitalstrasse 21, 4031 Basel

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