Face-to-face and blended
learning for corporate clients

Clinical Trial Management

Duration: 2 days

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

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

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

team

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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