The Certificate in Pharmaceutical and Clinical Trials Management is open to candidates from the pharmaceutical and biotech industries, as well as graduate students in the sciences and engineering. To receive the certificate, students must complete the course requirements listed below. Students pursuing their Master's or PhD must have their advisor fill out the graduate advisor form and submit it along with your application.
Overview
The certificate program is designed to educate students in the area of Clinical Trial Management. Students learn the key aspects of Clinical Trial design and conduct, and have the opportunity to be trained in the fundamentals of Regulatory Affairs. Students will also gain an understanding of the drug development process and have the opportunity to take a business course, such as project management. If a student chooses to continue their studies 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.
The objectives for the Certificate in Pharmaceutical and Clinical Trials Management include:
- Describe the important elements of a well-designed clinical trial
- 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
- Develop 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
- Write clinical trial and IRB protocols
Requirements
Students must complete a total of 15 credits (5 courses) and attend a total of 6 colloquia over the course of their studies. The program starts in January or September and completes in one year. Students can select 5 courses from the following list of courses - and may choose to take one business course.
Required Courses:
- 16:137:510 Drug Development from Concept to Market (3 cr) (Fall)
- 16:137:511 Drug Discovery through Preclinical Development (3 cr) (Spring)
Choose 3 from remaining list:
- 16:137:530 Principles of Accounting and Finance for Science and Technology (3cr) (Fall, Spring or Summer)
- 16:137:603 Fundamentals of Biological Chemistry in the Biotech Industry (3 cr) (Spring)
- 16:137:581 Statistics in Clinical and Translational Research (3 cr) (Spring)
- 16:137:582 Fundamentals of Regulatory Affairs (3 cr) (Spring)
- 16:137:501 Fundamentals of Intellectual Property (3 cr) (Summer)
- 16:137:580 Practical Aspects of Clinical Trial Design/Conduct (3 cr) (Spring or Fall)
Prerequisites & Admission
Candidates must have an undergraduate background in the biological sciences, chemistry, engineering or related field. Alternatively, those professionals that have been working in the Pharmaceutical industry for 5+ years but are from non-life sciences background, may apply for the Certificate in Pharmaceuticals and Clinical Trials Management.
For Industry Professionals with Life-Science Background:
Those professionals that have been working in the Pharmaceutical industry (more than 2 years experience preferred) may apply for the Certificate in Pharmaceuticals and Clinical Trials Management. To Apply, go to How to Apply & Admission Requirements and see “PSM Certificates General”.
For Industry Professionals with non-Life-Science Background:
Those professionals that have been working in the Pharmaceutical industry for 5+ years but are from a non-science 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.
For Graduate Students:
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 Non-degree Graduate Study. The admissions for all students will be handled by the Professional Science Master’s program office.
Alternate Path for an MBS degree in 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. Candidates apply for the Certificate in Pharmaceuticals and Clinical Trials Management. If Grades/GPA of B+ or higher are earned for the certificate, students may apply for the MBS degree program.
Please see the our apply now page for more information on how to apply to the program.
Certificate Coordinator:
For general inquiries and admission related queries, please email us at: psmadmissions@docs.rutgers.edu
For more information, contact: