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Clinical Trial Project Management Course Outline

Clinical Project Manager: Careers in Clinical Research

This class meets for 13 weeks, three hours a week of lecture delivered by one or two lecturers. Students will be assigned a clinical project in one of the four areas in the first class:
  1. Global clinical trials for a new drug
  2. Multi-site clinical trials for a new medical device
  3. Clinical testing of a new diagnostic kit
  4. Global clinical trials for a new vaccine
 Clinical Trial Project Management 
Clinical Trial Project Management Course Syllabus:

Class Date


Week 1

Overview Assignment of Course Project Introduction to the Drug Development Process: Drug development projects present unique challenges due to their complex multi-dimensional nature, long-term duration, and highly variable cost of operations. This week we will discuss the key elements of a drug development project, role of various personnel involved, basics of project management skills and their use in clinical projects. Also discussed will be the current status of biomedical industry and future trends, government and non-government agencies involved in regulating medical products, and life cycle and steps from R&D to post-marketing

Week 2

Introduction to FDA Regulatory Process: This week we will discuss the working of the US FDA and compare it to other international regulators. Topics discussed will include overview of FDA, its organization and responsibilities; laws, regulations, guidance, and suggestions from FDA; different kinds of FDA applications (IND, IDE, NDA, BLA, etc.); fees for FDA review, FDA enforcement processes such as audits, documents required, warning letters, penalties; how to interact with FDA.

Week 3

Clinical Trial Applications: This week we will discuss the clinical trial approval applications such as the Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications. Topics will include key components of clinical trial approval applications, basic principles of Good Lab Practices (GLP) and Good Manufacturing Practices (GMP), and logistics of an FDA application review process and its role in the clinical project planning. 

Week 4

Good Clinical Practices (GCP): Clinical trials need to follow certain universal standards described under GCP. All clinical trial professionals must have training in GCP. This week we will discuss US and international standards for conduct of clinical trials, roles and responsibilities of various personnel involved in clinical trials such as physicians, nurses, pharmacists, ethicists, advertisers, and investors. FDA Audits and the Bioresearch Monitoring Board

Week 5

Clinical Trial Protocol Development and Set-Up: This week we will discuss the basic elements of a clinical trial protocol, the dos and don’ts of clinical trial procedures, development of a new protocol, amending protocols, scientific and ethical review of clinical protocols. Training of doctors, nurses, recruiters, pharmacists, and ethicists, investigational product supplies management issues will also be discussed. 

Week 6

Statistical Design of Clinical Trials and Data Management: This week’s topics include common statistical parameters and standards used in clinical trials, statistical analysis plan and sample size calculation, source documents and Case Report Forms (CRF), data clarification process and common issues with data collection and management, data management issues for multi-site and global clinical studies, and role of Data safety monitoring boards (DSMB) 

Week 7

Introduction to Project Management for Clinical Trial Professionals:
The basic principles of project management will be discussed in this week. Techniques for defining scope of a clinical project, developing a project plan, creating teams and assigning roles, effective use of project management tools, role of SOPs in clinical trial management, preparing budgets and contracts, planning and scheduling issues unique to clinical projects, and an overview of costs and time for pharmaceutical development will be discussed. 

Week 8

Tools for Project Managers: This week we will discuss general project management tools and their use in clinical trials. Topics discussed will include MS Project, Gantt chart, SWOT analysis, defining deliverables, milestones, “go no go” decision making, management and leadership skills; team building and personnel development, best practices for communication and reporting for clinical trial projects, budgeting and time-line issues for clinical trials, project tracking, changes, and keeping schedule. 

Week 9

Human Subject Protection (HSP) and Informed Consent for Clinical Trials: Clinical trials involve testing of new products with unknown safety profile in people. Hence a key concern in clinical projects is how participants in clinical trials will be protected from unreasonable risk during the time they are on the clinical trial. This week we will discuss the history of human subject protection in clinical trials, the informed consent process, and role of Independent Review Boards (IRB) and other groups that oversee conduct of clinical trials. Also discussed will be assuring HSP in a national and multi-national trial. Finally, we will discuss different ways potential participants are made aware of clinical trials via advertisement and recruitment strategies. 

Week 10

Monitoring of Clinical Trials: Clinical projects involve extensive monitoring of all tasks and adverse events. This week we will discuss identification, qualification, selection, initiation, management and close­out of clinical sites. Techniques for monitoring data collection, verifying accuracy of reported data, and best practices for clinical monitors and coordinators - logistical planning, clinical monitoring reports, and fraud detection. This week we will also discuss task management and decision matrices in the context of clinical trial projects. 

Week 11

Adverse Event Management in Clinical Trials: One of the most important and unpredictable aspect of clinical trials is the adverse events that happen in the study participants. These adverse events may or may not be related to the tested product but irrespective of the cause, they need to be addressed so that the participants in whom they occur are appropriately treated, protected, and informed. Also adverse events need to be reported in a timely manner to FDA, IRB and other relevant parties. This week we will discuss the best practices for safety monitoring and management of adverse events in a clinical trial project. Also discussed would be safety reporting requirements, time-lines for reporting to regulators, and trouble-shooting. 

Week 12

Practical Issues with Clinical Project Management: This week we will discuss practical skills needed for clinical project management including communication and presentation skills, leadership skills, human resources skills, and personnel management. Also discussed will be the role and logistics of investigator meetings, best practices in communication such as reports, meetings, verbal and electronic discussions, contracting and budgeting issues for clinical trials, project completion and criteria for early termination of clinical projects.

Week 13

Final Project Presentation and Graduation: Each team presents their detailed project plan


This course is offered in partnership with Amarex
Clinical Trial Project Management  Home Page Clinical Trial Project Management  Course Syllabus
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Amarex logo

Amarex is a global Clinical Research Organization (CRO) that provides contract research services to pharmaceutical companies to assist in the development and eventual approval of the companies’ new medical drugs and devices. The basic services Amarex provides include: 1) the creation of product development strategies, 2) the conduct for human clinical trials, 3) the analysis of clinical trial data, and 4) the presentation of clinical trial results to the FDA to support the approval of a new medical product.

Job disciplines utilized by Amarex include: project management, review of medical records, database design and programming, data entry and data cleaning, statistics, medical writing, quality control, and regulatory affairs.  

Contact Us:
  • Transcie Almonte-Sabio, Program Director
  • Montgomery College, Workforce Development & Continuing Education
  • 12 South Summit Ave. 4th Floor
  • Gaithersburg, MD 20877

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