Industries: Pharma / Biotech

Clinical Trial Project Management, Phase 1-4 Best Practices

Course Director: Kay Monroe

Course Fee: $2650.00 Regular Registration / $2450.00 Early Bird (30 Days in Advance)

PharmaTrain Recognized Course  


Certification Tracks

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

Efficient and effective management of clinical trials can significantly impact the time, scope and budget for the development of a drug. Project managers must understand the development process and the key aspects of all phases of Clinical Development in order to act, react and adapt to change when the program moves forward and new data is acquired. Successful completion of Phase 1 and Phase 2 clinical trials are key project milestones to achieving proof of concept for any new drug. Phase 3 clinical trials are critical to gain regulatory approval for the market and Phase 4 allows expansion and extension of the indication for a drug. This course clinical trial manager training focuses on the best practices for developing and managing these trials within GCP guidelines and FDA regulations.

The clinical trial project management course will discuss the challenges associated with clinical trials run outside the United States and identify key differences, common pitfalls, and cultural differences. Guidance for the how-to as well as problem-solving for specific situations such as slow enrollment, high screen failures, or issues with data quality will be provided. The course is interactive and designed to allow for the exchange of ideas between peers in addition to learning from the instructor.

Who Should Attend

This clinical trial project management course is an overview designed for those in the Pharmaceutical and Biotech industries who will manage or direct projects within their functional area related to Clinical Trials. It will also benefit those who need an understanding of industry specific and project management best practices that should apply to their project. This course also applies for current project managers and others who may have cross-functional project management responsibilities.

Typical Clinical Trial Manager Training Attendees include:

  • Project Managers, Directors and Leaders
  • Clinical Investigators and Study Coordinators
  • Clinical Operations Directors and Senior CRA's
  • Clinical Trial Managers, Monitors and Associates
  • Medical Affairs and Clinical Operations Professionals
  • Pharmacovigilance and Labeling Professionals
  • Physicians and Medical Liaisons
  • Regulatory Affairs Professionals
  • Preclinical Development Professionals
  • Research and Development Scientists

Course Agenda

First Day

Drug Development and Project Management

  • Overview of the Drug Development Process
  • The History of Project Management

Overview of Clinical Phases – What are they?

  • Phase 0 or Exploratory INDs
  • Phase 1
  • Phase 2 (a/b)
  • Phase 3 (a/b)
  • Phase 4
  • Investigator Sponsored Studies

Clinical Development Tools

  • Target Product Profile (TPP)
  • Clinical Development Plan (CDP)
  • Protocol templates
  • Clinical Plan (CP)
  • Core Data Sheet or MIRS (Messages, Issues, Responses, Supporting Documentation)

Regulations Governing Clinical Research

  • Brief History of the FDA

Second Day

Regulations Governing Clinical Research (cont'd)

  • Good Clinical Practice (GCP)
  • International Conference on Harmonization (ICH)
  • Who is responsible? Sponsor, Monitor, Investigator

Ethics and Warning Letters

  • What they tell you and how can you apply those lessons?

Study Conduct

  • Timelines
  • Budgets
  • Risk Assessment
  • CROs and Outsourcing

Third Day


  • Working in China and India
  • Working in the Developing World
  • Common Issues to address – Culture, Language, Time Zone

Life Cycle Management

  • Keeping your Drug Portfolio alive
  • Extending Patent Life
  • Line Extensions, Re-Purposing, Re-Branding
  • Fraud and Misconduct

Team Conduct

  • High Performing Teams
  • Team Roles and Responsibilities
  • Communication, Negotiation & Conflict
  • Team Dynamics and Leadership

Learning Objectives

The course provides a thorough understanding of the activities involved during all Clinical Phase of Drug Development. The intent is to provide detailed knowledge of the project management practices, skills and tools that will make the difference between a successful clinical trial and one that does not meet its goals.

By the end of the course, participants should be able to do the following:

  • Understand the overall drug development process and the unique aspects of Phase 0 through Phase 4
  • Apply project management best practices to clinical trials
  • Manage a development project team and recognize team needs and leadership skills required for different stages of the drug development process
  • Refine the target product profile and position the drug for future submission, approval and launch
  • Understand GCP guidelines, FDA, EMA regulations and ICH guidelines
  • Understand and manage the challenges of clinical trials outside the USA
  • Develop accurate clinical trial timelines and budgets
  • Achieve high quality clinical data and optimize study logistics
  • Manage clinical supplies in your project plan
  • Manage adverse event reporting and protocol deviations
  • Prevent and manage fraud and study misconduct


"The Course Director is highly knowledgeable and very skilled in teaching and getting all participants involved. The course is illustrated with many practical anecdotes of real life experiences in the pharma world. The course also includes exercises that are very instructive. This three day course was really worthwhile." Hamidou T., Project Manager, SMB
"The course was exceedingly useful because of the interpersonal relationship of projects we have been involved with. I would recommend this course to others. It provides the "language" (the proper lingo) to articulate the management of clinical studies." Barrie T., President, American River Nutrition
"Excellent course – learned a lot, interesting examples of points. Break our sessions were really good – lots of interaction. A number of the topics I had not considered but the course presented these topics as applicable to my own business and would time/budget saving if implemented. Good ideas, excellent networking opportunity!" Dianne W., Clinical Research Associate
"Course Director was well organized and an effective speaker. I would certainly consider taking other courses from CfPIE and this Course Director" Danielle C., Regulatory Scientist, Merck
"It was fun, informative, and challenging. I will suggest to my peers to attend this course since it can be applied at any level of pharma." Gard W., Consultant, Nova Safety Consulting
"Absolutely excellent! I got far more information out of this course than I anticipated! Great speaker, great content!" Sandy H., President, Inspiring Minds Inc.

Frequently Asked Questions

If I have been managing clinical trials for some time, will this course be redundant for me?

Not necessarily. It could be viewed as a refresher. A wide variety of topics are covered, from managing time, scope and budget of a trial to the regulations for trials in the US, EU and Japan as well as team skills to manage staff involved in your trial. Every company manages studies differently, so there is a great deal to learn from participants as well as the instructor.

Will this course be useful for someone involved only with veterinary products?

Although the process of approval for new animal drugs is similar to human, there are enough differences that this course may not be useful if someone is involved only with veterinary products.

Is the course geared towards a specific therapeutic area?

The clinical trial management information is not specific for any therapeutic are, but can be utilized for all areas, in general. Some of the case studies and break-out sessions focus on a specific therapeutic area, but only for learning purposes.

Are device studies covered in this course?

No, device studies are not covered in detail, just in passing.

RAPS | Regulatory Affairs Professionals Society CfPIE is a Regulatory Affairs Professional Society (RAPS) RA Professional Development provider.

CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.  Click here for the list of courses reviewed and approved by RAPS.