Clinical Trials Manager

Clinical trials are essential to develop treatments, prove (or disprove) the efficacy of new pharmaceuticals, and reduce the recurrence of diseases. The fundamental questions they are looking to answer in clinical trials include does it work? Does it work better than other treatments? And what are the side effects? Clinical trials are performed on humans and provide information that cannot be collected in animal trials.

In order for clinical trials to run smoothly, there has to be a clinical trials manager who can handle both the business and medical sides of the trial. Clinical trial managers have to understand the trial’s objective and be able to manage the minutiae of day-to-day tasks to ensure the trial happens correctly. They also have to understand ethics and regulatory compliance in order to ensure the trial follows all necessary legal guidelines in order to be accepted.

To enter this field, professionals need education and work experience. Typically, clinical trial managers have a master’s or graduate certificate, although some can begin working with just a bachelor’s. Clinical trial work experience is critical; however, a professional needs to understand how trials run before they ever step into managing one. Often, two years of experience is the minimum requirement. This can be a lucrative career, with PayScale (2021) estimating that clinical trial managers earn $98,630 per year on average.

Here is a comprehensive guide to this profession, including program admission requirements, top educational training options, a step-by-step guide to joining this career, and certification and detailed licensing requirements.

Clinical Trials Manager Specializations & Degree Types

Clinical trial management professionals can enter this field with a variety of educational backgrounds. The most common educational path is to earn a bachelor’s, master’s, or certificate in clinical trial management or administration. However, professionals can enter this field with any combination of healthcare and management experience or education. To be successful in this field, professionals typically must have extensive experience in clinical trials.

Admissions Requirements for Clinical Trials Manager Programs

Completing an educational program can be an asset to any clinical trials manager. Admission requirements vary based on the type of program. Bachelor’s degree programs look for students who have completed high school or a GED, have ACT or SAT scores, and strong GPAs. They may require students to complete prerequisite undergraduate coursework before being admitted to the major as well.

Master’s degrees and certificate programs expect applicants to have already earned a bachelor’s degree. Undergraduate degrees must typically be in a healthcare-related field. Many master’s and certificate programs also require candidates to have experience already working in clinical trials or other aspects of health care.

Clinical Trials Manager Program Accreditation

Students should ensure the clinical trials manager program they choose is accredited. Accreditation assures students and employers that a program has met a high standard of quality in facilities, curriculum, and faculty. Since there is no programmatic accreditation for clinical trial manager programs, students should look for regional accreditation or another agency recognized by the Council for Higher Education Accreditation (CHEA).

On-Campus Clinical Trials Manager Degree Programs

Washington University in St. Louis – University College

Early-stage clinical trial managers can complete a bachelor of science in clinical research management at Washington University In St. Louis University College. With a strong foundation in science and management, this program prepares students to develop drugs, treatments, and devices in healthcare. This program’s focus is on developing scientific methods of clinical research, ethics, and regulatory guidelines.

In addition to general education coursework, students must complete 38 semester-credits in clinical trials management, specific classes. These classes include biomedical ethics, the business of clinical research, pharmacology for clinical research, and the fundamentals of clinical research management. All students must complete a comprehensive capstone project in order to graduate.

  • Location: St. Louis, MO
  • Duration: Four years
  • Accreditation: Higher Learning Commission (HLC)
  • Tuition: $56,300 per year

Eastern Michigan University – School of Health Sciences

Eastern Michigan University School of Health Sciences has both a certificate program and a master’s of science degree in clinical research administration. This program is a good option for aspiring professionals as well as professionals with extensive experience in the field. Courses are divided between lecture classes and hands-on experiences in order to produce quality clinical trial managers who can be an asset to any team.

The master’s program is 34 to 35-semester credits. There are 19 required core classes students must complete and then another 12 hours of electives to personalize their education. Electives include health law, public healthcare policy, neurochemistry, molecular genetics, and more. For admission to both the certificate and master’s, candidates must have a bachelor’s degree in any field, although science and healthcare-related degrees are preferred.

  • Location: Ypsilanti, MI
  • Duration: Two years
  • Accreditation: Higher Learning Commission (HLC)
  • Tuition: $1,718 per credit

The University of Texas Health Science Center at Houston

The flexible once-a-week lecture class format of the master’s in science in clinical research at the University of Texas Health Science Center at Houston is ideal for working clinicians. Because of this alternative schedule, it typically takes three years or more to complete this degree. Each student in this program is assigned a mentor who provides enterprise and guidance. This mentor plays a crucial role in helping to develop and complete the required practicum and thesis.

This program is intended for professionals who hold a graduate healthcare professional degree, such as doctors of medicine, doctors of pharmacy, or doctors of osteopathy. In addition to the master’s program curriculum, students are expected to complete the two-year clinical research curriculum, which are introductory courses in clinical research.

  • Location: Houston, TX
  • Duration: Three years
  • Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
  • Tuition: $505 per credit

Nova Southeastern University – Dr. Pallavi Patel College of Health Care Sciences

Students can earn a clinical trial management graduate certificate at Nova Southeastern University Dr. Pallavi Patel College of Health Care Sciences. This certificate must be completed in conjunction with the clinical research associate graduate certificate. Combining these two certificates gives aspiring clinical trial managers an understanding of how clinical trials work and the skills needed to manage one. There are five required classes in the research associate certificate and four in the clinical trial management certificate.

These certificates are part of the master’s in health sciences program, and all courses completed can be applied towards that degree, should students want to complete additional education.

  • Location: Fort Lauderdale, FL
  • Duration: Two semesters
  • Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
  • Tuition: $440 per credit

University of Chicago – Graham School of Continuing Liberal and Professional Studies

Students will gain a keen understanding of the entire clinical trials process, as well as gain the skills necessary to manage one, with the clinical trials management and regulatory compliance certificate at the University of Chicago Graham School of Continuing Liberal and Professional Studies. Graduates will know how to initiate a clinical trial, implement monitoring methods, adhere to regulatory requirements, and even detect fraud or misconduct.

Instructors in this program have an average of 10 years of experience in clinical trials. They teach classes such as the drug development process, fundamentals of clinical monitoring, and statistical concepts for clinical research. Admission requirements are easy to satisfy, with only a bachelor’s degree, current resume or CV, and a personal statement being required.

  • Location: Chicago, IL
  • Duration: Three quarters
  • Accreditation: Higher Learning Commission (HLC)
  • Tuition: $8,100 for the entire course

Online or Hybrid Clinical Trials Manager Degree Programs

George Washington University – School of Medicine and Health Sciences

The George Washington University’s School of Medicine and Health Sciences has online educational opportunities for clinical trial managers at all levels. They have a bachelor’s, certificate, and master’s program in clinical research administration as well as regulatory affairs programs. There is even a dual bachelor’s of science in health sciences and master’s of science in health sciences for ambitious students who want to complete extensive education.

Programs vary in length, with the certificate program taking only 18 months to complete and the bachelor’s programs taking approximately two years, as long as the appropriate number of credits are transferred (usually from an associate degree program).

Since these programs are offered online, students can complete their studies at their own pace while continuing to work. In fact, there are no on-campus visits required for this program at all.

  • Location: Washington, DC
  • Duration: 18 months to two years depending on the program
  • Accreditation: Middle States Commission on Higher Education (MSCHE)
  • Tuition: $635 per credit for undergraduate studies and $1,040 per credit for graduate studies

Arizona State University – Edson College of Nursing and Health Innovation

Aspiring clinical trial managers can complete an online master’s of science in clinical research management at Arizona State University’s Edson College of Nursing and Health Innovation. This 33-credit program prepares students to analyze and supervise clinical trials. Graduates of this program are employed in government agencies, universities, healthcare institutions, and research organizations. The required end-of-program capstone project allows students to gain practical clinical management experience.

Coursework students are required to complete includes responsible conduct of clinical research, fundamentals of regulatory affairs, clinical research operations, and scientific and research review boards. To be eligible for admissions, candidates must hold a master’s or bachelor’s degree and have completed coursework in anatomy, physiology, and medical terminology.

  • Location: Phoenix, AZ
  • Duration: 18 months to two years
  • Accreditation: Higher Learning Commission (HLC)
  • Tuition: $13,982 per year

Drexel University – College of Medicine

Learn clinical trial management skills from industry-leading professionals through Drexel University’s College of Medicine online master’s in clinical research management, organization, and administration.

While students must take courses in seven key areas of study, there is not a set curriculum so students can tailor their studies to their interests or career aspirations. Graduates will have advanced skills in research management and understand the business, ethical, and legal issues at play.

Upon completion of this program, students will be eligible to sit for either the ACRP or SOCRA certification. This program is geared towards professionals who already work in this field, so two years of relevant work experience are required to be considered for admission. Other admission requirements include already holding a bachelor’s degree with at least a 3.0 GPA, two letters of recommendation, a current resume, an essay on professional accomplishments, and official transcripts.

  • Location: Philadelphia, PA
  • Duration: Two to three years
  • Accreditation: Middle States Commission on Higher Education (MSCHE)
  • Tuition: $1,200 per credit

Rutgers, The State University of New Jersey

Professionals in pharmaceutical and biotech industries and graduate students in science and engineering can complete the online certificate in pharmaceuticals and clinical trials management at Rutgers. Students will learn how to design, conduct, and evaluate clinical trials. Credits earned for this certificate can be applied to a master’s in business science, should a student wish to pursue further education.

There are two required classes all students must take. They are drug development from concept to market and drug discovery through preclinical development. Students must also complete three elective courses in topics such as regulatory affairs, statistics, finance for science, and more. Classes are offered synchronously and asynchronously, depending on the subject and the instructor. Candidates for this program must have at least two years of work experience in the pharmaceutical industry or related field.

  • Location: Piscataway, NJ
  • Duration: Two to three semesters
  • Accreditation: Middle States Commission on Higher Education (MSCHE)
  • Tuition: $900 per credit hour

University of Delaware

The clinical trials management certificate at the University of Delaware’s Professional and Continuing Studies is a 14-week online program that offers a broad overview of clinical trials management concepts. It aligns with the ACRP exam content and prepares students to sit for the exam. Topics covered include ethics, safety, monitoring, oversight, regulatory compliance, and even branding and marketing.

Targeted at professionals already working in health care or clinical trials, this program is perfect for those looking to expand their knowledge or sit a certification exam. This program is only $2,125 for the entire course, and discounts are offered for military personnel, University of Delaware alumni, or early registration.

  • Location: Newark, DE
  • Duration: 14 weeks
  • Accreditation: Middle States Commission on Higher Education (MSCHE)
  • Tuition: $2,125 for the entire program

How Long Does it Take to Become a Clinical Trials Manager?

Depending on the education level pursued, it can take anywhere from four to seven or more years of schooling to become a clinical trials manager. In addition to education, aspiring clinical trial managers may need two or more years of work experience in clinical trials.

How To Become a Clinical Trials Manager – Step-by-Step Guide

Step 1: Graduate from High School or Complete a GED (Four Years)

Completing high school or earning a GED is the first step in a clinical trial manager career. Not only does this demonstrate a commitment to completing a course of education, but it also shows a student has attained a minimum level of education. Students who want to pursue this career should focus on classes such as math, biology, chemistry, business, and psychology.

Step 2: Attend an Undergraduate College Program (Two to Four Years)

A bachelor’s degree is generally required to work as a clinical trials manager. Students can either pursue a bachelor’s in science or health science. Major can include clinical trials administration, health science, biology, pre-med, or even business.

Step 3: Gain Work Experience in the Clinical Trials Field (Timelines Vary, Optional)

Work experience in clinical trials is often required in order to work as a clinical trials manager. Professionals can gain experience by working for pharmaceutical companies, universities, government agencies, or anyone conducting clinical trials. Experience with all aspects of a trial is essential, including design, planning, monitoring, and regulatory compliance.

Step 4: Obtain Certification (Timelines Vary, Optional)

Certification for clinical trial managers is voluntary, although it can be beneficial when applying for work or seeking a promotion. The primary certifying agencies are through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA). Certification requirements can be found in the certifications section below.

Step 5: Complete a Certificate or Master’s Degree Program (Optional, One to Two Years)

A master’s degree or certificate in clinical trial management can be advantageous when entering this field. Programs can be anywhere from one to three years or more in length. Typically, in these programs, students will learn ethics, trial design, regulatory compliance, and statistics.

What Do Clinical Trials Managers Do?

Clinical trial managers are employed everywhere clinical trials are conducted, including universities, government agencies, pharmaceutical companies, and nonprofits. Job duties vary based on the employer and the type of trial being conducted. However, typical responsibilities can include:

  • Working closely with a principal investigator to develop a clinical trial that meets objectives
  • Writing methods and recruiting patients to participate in the trials
  • Writing manuals for various aspects of the trial
  • Hiring clinical trials staff
  • Gathering and interpreting data
  • Making changes to the trial structure based on feed
  • Composing reports on the status of the trial
  • Compiling data at the end of a trial
  • Ensuring the clinical trial meets regulatory compliance standards

Clinical Trials Manager Certifications & Licensure

Certification is optional for clinical trial managers.

The primary certification pursued by professionals in this field is the Project Manager (ACRP-PM) Subspecialty Designation through the Association of Clinical Research Professionals (ACRP). To be eligible for this exam, candidates must hold another ACRP certification. Once eligibility has been determined, candidates may schedule a time to take the exam. This exam covers how project management principles can be applied to clinical trials.

Currently, there are no state licensing requirements for clinical trial managers. However, this can change at any time, so professionals in this field should contact their local clinical trials regulating agency or the Food and Drug Administration to ensure they have the necessary qualifications.

How Much Do Clinical Trials Managers Make?

According to the Bureau of Labor Statistics (May 2020), clinical trials managers are considered medical and health services managers. They earn $118,800 per year on average. The percentiles for wages are:

  • 10th percentile: $59,980
  • 25th percentile: $78,820
  • 50th percentile (median): $104,280
  • 75th percentile: $139,650
  • 90th percentile: $195,630

Clinical Trials Manager Career Alternatives

Here are few alternatives to a career as a clinical trials manager

Become a Clinical Trial Principal Investigator

Principal investigators lead and conduct clinical trials. They are the ones who lay the foundation for a successful clinical trial, then rely on investigators, clinical trial managers, and other staff to help them make it successful. They are also often responsible for the administration of any grants that may be used for the trial.

  • Typical Education: Doctorate
  • Licensing or Certifying Organization: Association of Clinical Research Professionals

Become an Administrative Services Manager

Administrative services managers are professionals who help organizations run smoothly. They are often also called business services managers. They can be responsible for supervising staff, ensuring facilities are maintained, mail distribution, and office upkeep.

  • Typical Education: Bachelor’s degree
  • Licensing or Certifying Organization: Various

Become an Insurance Underwriter

Insurance underwriters evaluate insurance applications and determine whether or not someone should receive coverage. Often they may also decide which type of coverage someone may receive and can set premiums.

  • Typical Education: Bachelor’s degree
  • Licensing or Certifying Organization: National Association of Insurance and Financial Advisors
Kimmy Gustafson

Kimmy Gustafson

Writer

Kimmy is a freelance writer with extensive experience writing about healthcare careers and education. She has worked in public health, at health-focused nonprofits, and as a Spanish interpreter for doctor’s offices and hospitals. She has a passion for learning and that drives her to stay up to date on the latest trends in healthcare. When not writing or researching, she can be found pursuing her passions of nutrition and an active outdoors lifestyle.

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