Face-to-face and blended
learning for corporate clients
gcp trainee

Clinical Trial Management

Duration: 2 days

Key Objectives:

Understand how to effectively manage clinical trials through applying a range of project management tools and techniques


Develop effective strategies and problem solving for managing clinical trials


Who should take this course?

This course is designed for those who newly or currently have a role involving clinical trial trial

management or would like to improve their trial management skills and techniques, including:

• CRAs, CTAs and Project Managers

• Clinical Trials Supplies Staff

• Medical Advisers

• Data Managers



Course Syllabus: 

1. Introduction and Objectives


2. Effectively Planning and Setting Up A Clinical Trial

• Planning and trial set up

• Avoiding repeating past failures in clinical trials

• How to use project management tools and techniques in clinical trials

• Risk and contingency planning

• Understanding the importance of effectively communicating the objectives of the clinical project

• Planning resources and realistic budgets

• Identifying and selecting investigators


3. Managing the clinical phase and end of study activities

• Consider how to overcome typical constraints in clinical trials

• Effective communication with your clinical research team and senior management, including -

How to avoid misunderstandings and conflict when communicating with different nationalities


4. Working effectively with clinical research organisations and/or Site Management

Organisations (SMOs)

• Discusson of selection and management considerations/issues


5. Identifying the causes of poor patient patient/subject recruitment and finding

solutions to proactively manage these issues

• Including the considerations for recruitment of patients to international studies


6. The Integration of people skills with clinical trial tasks and processes

• Leadership skills for clinical trials

• Understanding the stages of team development, and how to build a high performing



7. People skills - continued...

• Motivation of yourself and your team members, persuasion, co-operation & consensus-

building with team colleagues, CROs and Investigators

• Identify and find solutions to common time wasting activities in clinical research projects


8. Personal Action Planning – preparing a plan to apply what you have learnt from the

course into your clinical trials in your everyday role

9. Managing clinical trials post Brexit


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