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

The Master of Science in Clinical Trial Management is a highly-selective program for students with a strong background in any biological science area that includes medicine, nursing, dentistry, pharmacy, microbiology, biotechnology, biochemistry, and the similar regions. Students with a background in information technology, biostatistics, and other general commerce and finance backgrounds can also take this as an additional specialty option after some prerequisite training.

In this Course

Students will learn about developing complete regulatory activities involved in creating documents and conducting, recording, monitoring, and reporting clinical trials. Our Graduate program includes 20+ weeks of Internship to provide rigorous

hands-on experience in Clinical Trial Management System (CTMS), Electronic Trial Master file (ETMF), Argus safety database, adopted by the pharmaceutical industry today, and in SAS (Statistical Analysis System). It will be done through real-time Case Scenarios, Clinical Tasks, and other Site Management activities taught by industry experts who work in the related domain and have vast experience in day-to-day operations.

Clinical SAS programming and Risk-Based Monitoring is one of the important electives in the program. In the Clinical SAS module, the Base is covered along with Advance SAS Programming, including CDISC, SDTM, and ADAM.

In Clinical data science, the track will deal with basics of statistics, introduction to sampling techniques, probabilities, and statistical tests for discrete and continuous random variables including R, Data Visualization, and SQL. We get to machine learning in this track, where we explore multiple supervised machine learning algorithms for regression, time series analysis, classification, and unsupervised learning techniques such as clustering. We will deep dive into neural networks and that an industry project related Pharma is executed.

Students can apply to various roles: Clinical Research associate, Clinical research coordinator, Clinical research assistant, Clinical data analyst, clinical SAS programmer, Clinical data Scientist, Data Entry specialist.

 

Highlights

  • 20+ weeks of hands-on training in Clinical Trial Management System, Electronic trial Master file, and SAS.
  • SAS Academic partner with hands-on projects on SAS, CDISC, SDTM, and ADAM
  • Clinical Programming knowledge of Data mining, SQL, Data Visualization, various system data science.
  • Understanding of Risk-based monitoring, Ethics, and safety, Quality management and Audits In Clinical Trials
  • The students will access the program content, class recordings, and tool access up to 1 year of program completion.
  • We provide them with references for the jobs as Clinical Research Intern upon completing the Academic internship.
  • Students are guided by our Industry Career Advisors with more than 15 to 30 years of related domain experience. These Advisors guide the graduates in resume and interview preparation in a small group and one-on-one sessions.
  • Students are guided by our Industry faculty with more than 15+ years of experience in resume and interview preparation.

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 FDA regulates the drug commercialization process.
  • Learn about the roles and responsibilities of sponsors, principal investigators, and regulators in clinical trials.
  • Prepare budgets, contracts, and financial disclosure documents required for ongoing trials.
  • Understand HIPAA law, the protected health information, and its implications.
  • Explain clinical trial management (CTM) by understanding the fundamental concepts of study planning, study setup, conduct, and closeout.
  • Students can choose the Argus safety database as one if there specialty in their semester.
  • Describe data manipulation techniques using SAS DATA and procedure steps to access, transform, and summarize SAS data sets.
  • Clinical Data mining helps to understand the clinical application’s programming aspect introduction to sampling techniques, probabilities, and statistical tests for discrete and continuous random variables. Then we start with understanding R as a tool, basics of R, exploratory data analysis in R. Later, we get to machine learning, where we explore multiple supervised machine learning algorithms for Regression.
  • Understand the concepts Risk-based monitoring, Ethics and safety, Quality management, and Audits In CT

Syllabus

  • Study Start-up
  • Study Conduct
  • Study Close-out
  • Internship

PTM605        Project Management

LTR 606        Literature Review

Electives

DM 607         Clinical Basic of Data Mining

SAS 608        Clinical Base SAS

DSP609         Introduction to Drugs, Safety and its Regulations

Track 1

Clinical Pharmacovigilance

  • DSP610         Adverse Events Reporting and Post-marketing Activities
  • DSP611         Introduction to Oracle Argus Safety Application Part I

Track 2

Clinical SAS Analytics

  • SAS Advance 612
  • SAS Clinical 613
  • SQL 614

Track 3

Clinical Data Science

  • DM 615                    Advanced Clinical Data Mining
  • DV Tableau 616     Clinical Data Visualization with Tableau
  • SQL 617                   Structured Query Language

Track 4

Clinical Risk and quality management

  • CTM 618      Risk Based Monitoring
  • CTM 619      Ethics and Safety Compliance in Clinical Trials
  • CTM 620      Quality Management and Audits in Clinical Trials
  • Capstone Project/Externship

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


Dr.Nimita Limaye

Faculty of Clinical Research


Prof Padma Iyer

Faculty of Clinical Research


Dr.Shabana Dange

Faculty of Clinical Research


Mr Balachandra Kandukuri

Faculty of Clinical Research


Course Duration

Duration

2 Years 

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

Credit transfers applicable for alumni

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.