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     Certificate in Pharmaceuticals and Clinical Trials   Management

The Certificate in Pharmaceutical and Clinical Trials Management is open to all graduate students in the sciences and engineering, part-time students from industry, and post-doctoral fellows. This certificate is also available to those who have already completed their M.S. and Ph.D. degrees as graduate certificate. To receive the certificate, students must complete all the course requirements listed below.

The certificate program is designed to introduce students to the Management of Clinical Trials. Pharmaceutical industries and businesses today need workers who not only possess up-to-date knowledge in their fields, but who have also acquired skills that enable them to carry out the objectives of the regulatory bodies, such as the FDA, in ensuring public health. Such workers understand the linkage between risk versus benefit in the pharmaceutical industry and businesses. The certificate reviews key aspects of Clinical Trials design and conduct and provides students with practical skills in communication and leadership skills. This certificate offers students an opportunity to combine management skills with the drug development process. Students will have the opportunity to explore regulatory affairs as a prospective career path. If a student chooses to pursue the MBS degree with a concentration in Drug Discovery and Development, all credits earned are transferable to the MBS degree, pending approval to the graduate program.

Goals:
The goals for the Certificate in Pharmaceutical and Clinical Trials Management include the following:

• to describe the important elements of a well-designed clinical trial
• to design randomized controlled trials and compare the advantages and disadvantages of various clinical trial designs e.g., retrospective, case-control, cohort
• identify potential sources of bias in clinical trials, and select strategies to eliminate or control for bias,
• apply various biostatistical descriptors and techniques to clinical trial design and use them to interpret results.
• understand the developmental pipeline for small molecule and biological drugs, and the economic aspects of small molecular and biological drug development,
• understand intellectual property and regulatory issues at transitional phases in the development process
• have a clear understanding of why ethics are important in clinical research and be familiar with the regulatory practices in place to protect both the researcher and the subject.
• learn about the basic statistical procedures used to analyze data and be able to apply these techniques utilizing a standard statistical package.
• to write clinical trial and IRB protocols.
• develop oral, written and team based skills needed to analyze potential markets and the ability to communicate findings to decision makers.
• to understand the connection between technology and business and how technical work impacts the business of organizations.
• to understand the core elements required to design and operate an effective, science driven organization and how to diagnose and solve organizational problems.

Prerequisites & Admission
Current graduate students enrolling in the certificate program should have the permission of the graduate director in their program. A formal application to the certificate program for admission is required before registering for classes. Requirements for admission include current status as a graduate student in the sciences or engineering (you are eligible after your first semester of studies), a graduate degree in the sciences or engineering, or equivalent work experience. Individual students should discuss their academic preparation with the Certificate Coordinator to determine whether the prerequisites have been fulfilled or to determine an appropriate suite of classes to fill any gaps. Students who are not currently degree students at Rutgers can apply to take the certificate through Nondegree Graduate Study. The admissions for all students will be handled by the Professional Science Master’s program office.

Alternate Path for MBS-Drug Discovery and Development:

For only those with 5+ years’ experience in the field. Must be proficient in biology, chemistry, organic chemistry and must have a background in physiology, genetics, cell biology, molecular biology and biochemistry: Apply for the Certificate in Pharmaceuticals and Clinical Trials Management; no GRE’s required. (If Grades/GPA B+ or higher in the certificate, then may apply for MBS degree. GRE will be waived.) Contact PSM office for more information.

Certificate only option - non Life Sciences:
Those professionals that are in Pharmaceutical industry for 5+ years, but are from non life sciences background, may Apply for the Certificate in Pharmaceuticals and Clinical Trials Management. For example, someone involved with clinical science data management or regulatory affairs may be eligible for the certificate only option. You should do the following courses: Regulatory Affairs, Concept to Market, Communication & Leadership, Ethics, Colloquium and Intellectual Property. Please contact PSM office for more information.

Requirements
The requirements to complete the certificate program are listed below. There are a total of 15 credits in the certificate program encompassing the basic topics of clinical trials design, conduct, ethics, regulatory affairs, communications, leadership, and project management. Also, students must attend a colloquia over the course of their studies (6 in total). Individual course descriptions are given after the table.

Click here for course descriptions.

For cost per credit, please visit our Finance page.

Certificate Coordinator:

Dr. Sangya S. Varma
sangya@rci.rutgers.edu