Clinical Trial Project Management (CTPM)
A collaborative program among Montgomery College and Amarex Clinical Research - A pharmaceutical product development company. Clinical Project Manager – Careers in Clinical Research.
Get yourself added to our registration reminder list by emailing Noel Lazaro atnoel.lazaro@montgomerycollege.edu
An email will be sent to you 1-2 weeks before FALL 2022 registration opens. Space is limited.
*The CTPM course is only offered once each fall term*
Registration For Fall 2022 is now open!
本课程介绍制药行业临床试验的项目管理。如果你想学习基本的项目管理技能，以及如何将其应用到药物开发过程中，特别是临床试验的管理，这门课程非常适合你。如果你正在寻找临床开发行业的职业，但对临床试验管理中涉及的具体技术任务不熟悉或缺乏经验，本课程适合你。本课程将带领您了解临床试验项目的各个方面，特别关注以积极主动的方式预测、理解和实施详细的项目管理活动的必要性。本课程将帮助学生了解一个非常详细和全面开发的临床试验管理项目。研讨会将由业界专家带领，通过个案研究和模拟临床试验项目，培训学员在临床项目的实践方面，以确保成功的临床项目管理职业生涯。
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.Clinical Trial Project Management flyer(PDF,
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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 and Amarex reserve 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.
Our Partner – 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.
The Clinical Trial Project Management (CTPM) Course at Montgomery College is offered in partnership with Amarex Clinical Research Organization (CRO) once each Fall Term. Space is limited each fall. Montgomery College does not offer job placement upon course completion.