Master of Science in Clinical Trial Management

Work with the latest industry tools and learn how to apply them in the domain of clinical trials.

OVERVIEW

Why Clinical Trial Management

Learn about the complete Regulatory activities involved in Creating Documents; and in Planning, Organizing, Monitoring, Recording, Analysis and Reporting of Clinical Trials in Human Beings. Also learn about recent advancements as well as specializations in e-Clinical Technology.

In This Course

Delve into concepts of personalized medicine, gain an overview of the theory of medical decision-making concepts necessary for performing systemic reviews and meta-analyses, and learn how to write a grant proposal for the NIH.

The Sollers Advantage

Our Clinical Trial Management program is taught by faculty experienced in the industry. Gain extensive hands-on experience in Oracle Clinical, which is the most widely used Clinical Data Management System (CDMS) adopted by the pharmaceutical industry today, and in SAS (Statistical Analysis System).

Learning Outcomes

  • Describe the basic concepts of drug discovery and the tools that are used in drug discovery.
  • Understand ethics, federal regulations, good clinical practice (GCP), and how the FDAregulates the drug commercialization process.
  • Learn about the roles and responsibilities of sponsors, principal investigators, and regulatorsin clinical trials.
  • Prepare budgets, contracts, and financial disclosure documents required for ongoing trials.
  • Understand HIPAA law, the protected health information, and its implications.
  • Explain the concept of clinical trial management (CTM) by understanding fundamentalconcepts of study planning, setup, conduct, and closeout.
  • Describe data manipulation techniques using SAS DATA and procedure steps to access,transform, and summarize SAS data sets.
  • Understand clinical trial design, analysis, and outcome in cardiovascular trials, respiratorytrials, infectious diseases, vaccine trials, pain management trials, surgical procedures,reproductive health, paediatrics, and geriatrics.
  • Understand the steps and methods involved in initiation, selection, and closeout ofinvestigational sites.
  • Understand the grant application process for the National Institutes of Health (NIH) and theNIH’s Research Portfolio Online Reporting Tools (RePORT).

Syllabus

  • Study Start-up
  • Study Conduct
  • Study Close-out
  • Internship
  • Clinical Data Management and Oracle Clinical
  • Project Management
  • Literature Review
  • Risk-based Monitoring
  • Ethics and Safety Compliance in Clinical Trials
  • Quality Management and Audits in Clinical Trials
  • Medical and Regulatory writing in Clinical Trials
  • Applied Biostatistics II
  • Base SAS and SAS Clinical
  • Process of Medical Device compliance
  • Internship

INTERNSHIP

Sollers offers an internship as part of the Master of Science in Clinical Trial Management program that helps you gain practical experience on key concepts taught during the course.

Upon successful completion of the program, a certain level of skill and expertise is expected of students to get placed with our industry-leading corporate partners.

Instructors

Our instructors are not just highly experienced in the industry, they give you the personal attention you need and guide you every step of the way.

Mark Koscin

Faculty of Clinical Research


Kamal Akhtar

Faculty of Clinical Research


Eileen Caramanica

Faculty of Clinical Research


Course Duration

Duration

2 Years 

For information regarding fee and/or reserving your spot, contact our Admissions Team.

OUR STUDENTS WORK AT

Sollers partners with industry-leading corporations and provides them with ready-on-day-one employees. We record an 82% placement rate within three months of graduation.

Financial Options

Sollers has devised viable financial options for you to ensure tuition does not get in the way of your education. Now, you can focus your attention where it needs to be – in the classroom!

Career Guidance

After the completion of program, we assist our students with interview coaching, resume building sessions, conduct mock interviews, job readiness training and make them competent to venture into the corporate world.

Student Testimonials

  • Emmanet T.
    The Clinical Trial Management course is extensive, and the professors are thorough in delivering the course materials using real life experience and insight. Career Services helped me throughout the interview process, and I landed my dream job with the very first interview after graduating from Sollers.
    Emmanet T.
  • Rudolf M.
    Thanks to the academic team at Sollers, I was able to gain quick admission with financial options to pay tuition. Career Services was very helpful with resume and interview prep. They sent me job postings with major hospitals and pharma companies which helped me land my current job as Data Manager in cancer clinical trials.
    Rudolf M.

FAQs

According to Marketwatch, a Bachelor’s Degree holder will earn over 26% more money than an Associate’s degree holder with similar experience. Higher education has never been more important, in today’s fast-paced, technology-driven, highly competitive world. While you don’t have to invest in 4-5 full years in education if you don’t want to, getting an accelerated Bachelor’s degree like this one will definitely allow you to take few special courses and give you a head-start to set you on a right career track.

The high growth of the industry and career prospects in clinical research are already stated in the introduction above. There is practically no other comparable bachelor’s degree program in clinical research in the market today: that’s right, this is the first-of-its-kind accelerated bachelor’s degree to help you start in the lucrative career of clinical research in almost half the time and investment you’d have to put in a traditional masters or bachelors degree. Once you sign up, you get the training as well as relevant experience through our internship, to show for your first job – something that is extremely hard to get these days. Our career services team prepares you through career counselling, resume reviews, mock interviews and soft skills training. Not convinced yet? Contact us to discuss how we can specifically help you and how exactly can this program add value to your career.

This is an accelerated bachelor’s program. This associate to bachelor’s degree program is for total of 60 credits, and can be completed in a year and a half to two years.

Yes, we can allow credit transfer upon certain conditions; however, each request will be evaluated case-by-case basis. Please contact us on admissions@sollers.edu to learn more.

There are no prerequisites, except that you need an Associate degree, preferably in any of the life sciences, biological sciences or relevant areas.

One of the key highlights of this program is the internship and hands-on, practical projects – all of which give you the relevant experience to not only understand and talk intelligently about clinical research, but help you get that first job in the industry. You will gain extensive practical sessions in Clinical Trial Management systems, Oracle Clinical – most widely used data management system in pharmaceutical industry – and SAS (Statistical Analysis System) as well as use electronic Trial Management File.

Industry Facts

Given the fact that people are going to fall sick, and pharmaceutical industries will have to continue producing life-saving drugs, clinical research is a recession-proof, one of the hottest careers today. Also, as personalised medicine becomes more common, clinical trials will increasingly be needed to make sure drugs and devices work properly.

The global clinical trials market was valued at US$40 billion in 2016, and is expected to reach US$65.2 billion by 2025, according to a recent grand view research report. North America dominated the overall market due to big outsourcing firms and increase in R&D, according to the same report. According to the Scientist’s 2015 Life Sciences Salary report, Clinical Research is one of the top hot fields and ranks second in salary.