The 34 graduates have completed A 39-hour program that prepares them for pharmaceutical product development and clinical trial careers

Montgomery College, county and business partners, and pharmaceutical industry leaders will convene Saturday, December 12 at 9 a.m. in a virtual graduation ceremony for 34 students who have completed the Clinical Trial Project Management (CTPM) program. As vaccine development has been at the forefront of biomedical research this year, experts will share their knowledge on conducting clinical trials in the pharmaceutical industry to follow processes and satisfy FDA requirements before market approval of biomedical products. The 10-year-old program, which requires a bachelor's degree of any kind for entry, has trained more than 300 trial managers. 

A collaborative program among Montgomery College and Amarex Clinical Research, a pharmaceutical product development company, the "Clinical Project Manager: Careers in Clinical Research" program introduces project management of clinical trials in the pharmaceutical industry. The non-credit course is for anyone who wants 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 workforce skills building course is also useful for those looking for careers in the clinical development industry but are not familiar, or experienced, with specific technical tasks involved in clinical trial management. 

The Saturday presentation features experts from Amarex, AstraZeneca, Montgomery County and the College:

clincialtrial

The course walks students 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. Students will learn a highly detailed and fully developed clinical trial management project. Discussions are 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 numbers 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

There are also new topics/activities each week:

  • 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

To attend the virtual project presentation and graduation, please see details below.

When: Dec 12, 2020 09:00 AM Eastern Time (US and Canada) 

Register in advance for this Presentation:

https://montgomerycollege.zoom.us/meeting/register/tJwvc-ipqj8pHNbv_RQwqtvdrvc05Ns3QSqM  

After registering, you will receive a confirmation email containing information about joining the meeting. 

NOTE: There will be no questions from media during or after the presentation. Interviews will be furnished upon request.

About Amarex

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. 

About Montgomery College

Montgomery College is a public, open admissions community college with campuses in Germantown, Rockville, and Takoma Park/Silver Spring, plus workforce development/continuing education centers and off-site programs throughout Montgomery County, Md. The College serves nearly 54,000 students a year, through both credit and noncredit programs, in more than 100 areas of study.  

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