Clinical Trial Project Management (CTPM)

This course provides an introduction to project management of clinical trials in the pharmaceutical industry. If you want to learn basic project management skills and how they can be applied to the drug development process, especially in the management of clinical trials, this course is for you. If you are looking for careers in the clinical development industry but are not familiar, or experienced, with specific technical tasks involved in clinical trial management, this course is for you.

This course will walk you through the various aspects of clinical trial projects with special focus on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. This course will help students understand a highly detailed and fully developed clinical trial management project. Discussions will be led by industry experts via case studies and mock clinical trial projects to train students in the practical aspects of clinical projects to help assure a successful clinical project management career. 
With increasing number of clinical trials conducted to satisfy FDA requirements for marketing approval of all biomedical products, demand for clinical trial professionals is on the rise. However, there are very few programs that provide comprehensive education in all major components of clinical projects. Clinical Project Manager: Careers in Clinical Research introduces the core competencies essential for successful clinical project career. 

This 39-Hour Program is divided into four modules, providing training in the following areas:

• Clinical protocol development 
• Regulatory processes 
• Clinical site selection, training and management 
• Clinical monitoring 
• Safety Monitoring 
• Data management 
• Statistical analysis of clinical data 
• Human subject protection and ethics

 Course Topics 

There will be a new topic/activity each week. This may include:

• Overview Assignment of Course Project / Introduction to the Drug Development Process
• Introduction to FDA Regulatory Process
• Good Clinical Practices (GCP)
• Clinical Trial Protocol Development and Set-Up
• Human Subject Protection (HSP) and Informed Consent for Clinical Trials
• Introduction to Project Management
• Data Management
• Statistical Design of Clinical Trials
• Clinical Project Management
• Adverse Event Management in Clinical Trials
• Monitoring of Clinical Trials
• Mock Presentation / Practical Issues with Clinical Trial Project Management
• Final Project Presentation

Montgomery College reserves the right to change and alter the topics and activities listed. Final syllabus and topics are given to registered students on the first day of class.