Overview

In the complex environment of today’s clinical studies, with about 40% of studies failing to perform as expected, the need of skilled clinical project managers keeps increasing.

We designed this course for junior clinical project managers in small and medium sized pharmaceutical and biotechnology companies to navigate them through the science of project management, equip them with knowledge and tools to manage studies successfully, point out common misconceptions and pitfalls to avoid, and get them ready to fulfil their company goals in regulatory-compliant study execution.

Starting with general project management principles and terms, we apply them on clinical studies, focus on thorough project planning, share ways and tools for a strong project control, define how to close the project properly, and take lessons learned for future projects.

This 4-half-day course is practical and interactive with opportunities to get engaged in workshops, discussions, sharing of experience, and networking.

Featured topics

Project Management standards, guidelines, phases and gates
Risk Management lifecycle and tools
Project start-up, implementation, control and closing
Regulatory environment, guidelines and regulations, GXP vendors, challenges in global studies
Clinical Trial budgeting
Quality by design and risk-based quality management in clinical trials
GCP vendor management

Who should attend?

This course is designed for junior clinical project managers in small and mid-sized pharma and biotech companies such as:

Clinical Project Managers wishing to hone their knowledge and skills in clinical risk management and vendor management
Clinical Project Managers with 0-2 years of experience
Clinical Team Leads supporting clinical project management
Persons planning to become Clinical Project Managers
Study Start-up Managers
Clinical Project Assistants
Line managers of clinical personnel
QA personnel wishing to have more insights in clinical project management to support quality deliverables

A sound knowledge of GCP is a must. A practical experience in conducting clinical studies is desirable.

Learning objectives

Apply general project management and risk management principles in clinical studies.
Choose the right clinical project management tools.
Design quality outcomes during the planning phase and manage clinical studies creating a “no surprise” environment.
Manage GCP vendors based on continuing risk assessment and monitoring.
Prevent and/or resolve common challenges in clinical study conduct and deliver quality outcomes.

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