“Clinical trial managers need to have high organizational and communication skills and pay deep attention to detail to maintain the credibility of the research being conducted. They are the heroes behind the scenes who ensure potentially life-saving treatments can be tested before they can reach patients.”
Shwetha Pazhoor, MS, Program Manager of Research Compliance at UTHealth Houston
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 want 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 animal trials cannot collect.
For clinical trials to run smoothly, there has to be a clinical trial 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 to ensure the trial follows all necessary legal guidelines 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 must understand how trials run before they ever step into managing one. Often, two years of experience is the minimum requirement.
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.
| Featured Clinical Research Administration Programs | ||
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| Arizona State University | Clinical Research Management (Graduate Certificate) | Visit Site |
| Arizona State University | Clinical Research Management (MS) | Visit Site |
| Arizona State University | Regulatory Science (MS) | Visit Site |
| Johns Hopkins University AAP | MS - Regulatory Science | Visit Site |
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Meet the Expert: Shwetha Pazhoor, MS
Shwetha Pazhoor is the program manager of research compliance at UTHealth Houston. After receiving her master’s degree in biosciences from Mangalore University in India, she began her career as a research assistant at the University of Texas MD Anderson Cancer Center, where she did bench work research before moving into the field of clinical trials. She worked at MD Anderson Cancer Research Center for five years as a senior clinical studies coordinator managing multicenter and international clinical trials. Her vast experience in managing clinical trials landed her a position at UTHealth Houston in 2019 as a research compliance specialist. In her current role, Pazhoor conducts internal GCP audits of principal investigator-initiated trials, organizes training for junior faculty and research coordinators, and helps study teams with the registration of studies in clinicaltrials.gov.
HealthcareDegree.com: What is something you wish the public understood about clinical trial managers?
Pazhoor: One aspect I wish the public understood about clinical trial managers is the critical role they play in ensuring the safety, integrity, and success of clinical trials. They are responsible for overseeing every stage of a trial, from protocol development to patient recruitment, data collection, and study analysis. They work closely with the investigators and study sponsors to ensure the study is conducted ethically and follows good clinical practices. They are also the main contact between the participant and the investigator. They are also responsible for addressing any challenges or deviations that may arise during the trial, such as protocol amendments, adverse events, or logistical issues.
Clinical trial managers need to have high organizational and communication skills and pay deep attention to detail to maintain the credibility of the research being conducted. They are the heroes behind the scenes who ensure potentially life-saving treatments can be tested before they can reach patients.
HealthcareDegree.com: What advice would you give to aspiring clinical research management students?
Pazhoor: Some advice I would give aspiring clinical research professionals includes:
- Develop a strong ethical foundation: This is very important for any research. Gain as much ethical knowledge about the principles of clinical research. Get certified if possible. Look for programs and trainings offered in your city.
- Gain hands-on experience: This is one of the most important pieces of advice. Gain on-the-job experience, which could include internships, volunteer work, or even part-time positions in research. Practical experience will help you learn the day-to-day details of the job in the real world.
- Know organizational communication skills: Learn to effectively communicate with the participant, investigator, sponsor, and other study team members. Be transparent and bring any problems that arise to the investigator’s attention as soon as possible. Be very organized and try to complete tasks on the same day they happen to avoid errors.
- Stay updated: The world of clinical research is constantly changing, and staying updated is a task in itself. Make sure you stay updated by reading newsletters, attending conferences, and being part of the research community in your city.
- Network: This is very important in this career field. Build a strong network. Ensure you are part of the local Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) chapters. Attend conferences and talk to people in your field. Connect to other research professionals via LinkedIn.
Always prioritize ethical conduct in your work, build a strong foundation on all regulations, keep up with changes, be organized and communicate effectively, be ready to learn and grow, and build a strong network around you. Always remember that new, innovative medicine is possible only because of the hard work of people like you who work tirelessly behind the scenes.
Clinical Trials Manager Specializations & Degree Types
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Clinical trial management professionals can enter this field with various 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 have strong GPAs. They may also require students to complete prerequisite undergraduate coursework before being admitted to the major.
Master’s and certificate programs expect applicants to earn bachelor’s degrees. Undergraduate degrees must typically be in a healthcare-related field. Many master’s and certificate programs also require candidates to have experience working in clinical trials or other aspects of healthcare.
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-quality standard 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
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 expertise and guidance. This mentor plays a crucial role in helping to develop and complete the required practicum and thesis.
This 36-credit program is intended for professionals who hold a graduate healthcare professional degree, such as doctors of medicine, doctors of pharmacy, or doctors of osteopathy.
The curriculum comprises two tracks: a patient-based clinical research track and a translational research track. In addition to the formal coursework, students are required to complete three practicums and a thesis, which is ultimately orally defended. Courses include methods of economic evaluation in clinical research, advanced clinical research study design, and advanced biostatistics for clinical investigators.
All students will also be required to complete the ‘clinical research curriculum’, which is a two-year series of introductory courses. Completing this clinical research curriculum will yield up to twelve credits toward the MS degree credit requirements.
- Location: Houston, TX
- Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
- Expected Time to Completion: Three years
Washington University in St. Louis – School of Continuing & Professional Studies
Early-stage clinical trial managers can complete a bachelor of science in clinical research management at Washington University in St. Louis’ School of Continuing & Professional Studies. 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 to graduate.
- Location: St. Louis, MO
- Accreditation: Higher Learning Commission (HLC)
- Expected Time to Completion: Four years
Eastern Michigan University – School of Health Sciences
Eastern Michigan University School of Health Sciences offers both a certificate program and a master’s of science degree in clinical research administration. This program is a good option for aspiring professionals and professionals with extensive experience in the field. Courses are divided between lecture classes and hands-on experiences to produce quality clinical trial managers who can be an asset to any team.
The master’s program is 34 to 35 credits. Students must complete 19 required core hours and then another 12 hours of electives to personalize their education. Electives include health law, public healthcare policy, neurochemistry, molecular genetics, and more. Core classes include introduction to drug development, clinical study administration, advanced topics in clinical study management, ethical issues in clinical research, and introduction to regulatory affairs in drug development.
The graduate certificate requires completion of 15 credits. Courses include an introduction to drug development, clinical study administration, advanced topics in clinical study management, and a preceptorship in clinical trial management.
Candidates must have a bachelor’s degree in any field, although science and healthcare-related degrees are preferred, for admission to both the certificate and master’s programs.
- Location: Ypsilanti, MI
- Accreditation: Higher Learning Commission (HLC)
- Expected Time to Completion: Two years
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.
The 12-credit clinical trial manager graduate certificate includes courses such as enterprise risk management, health care systems and conflict, applied statistics, and clinical trial manager. The 15-credit clinical research associate graduate certificate includes courses such as research ethics, clinical trial process, legal, safety, regulatory compliance, and best practices, reporting clinical trial results in different media & externships, and clinical trial conduct.
- Location: Fort Lauderdale, FL
- Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
- Expected Time to Completion: Two semesters
Online or Hybrid Clinical Trials Manager Degree Programs
George Washington University – School of Medicine and Health Sciences
George Washington University’s School of Medicine and Health Sciences offers online educational opportunities for clinical trial managers at all levels. They offer bachelor’s, certificate, and master’s programs in clinical research administration and regulatory affairs. There is even a dual bachelor’s of science in health sciences and a master’s of science in health sciences for ambitious students who want to complete extensive education.
Programs vary in length, but the certificate program takes only 18 months to complete, and the bachelor’s programs take 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, no on-campus visits are required for this program at all.
The master of science in health sciences in leadership and strategy in regulatory affairs and clinical research administration program will provide practical knowledge to students about the key elements of regulatory affairs and clinical research administration from a global perspective. Incorporating global regulatory strategy and clinical research industry-specific concepts across the curriculum, the program equips students with the critical thinking skills they need to succeed in these fields. This 36-credit program includes courses such as introduction to global regulatory affairs and clinical research, regulatory strategy in the development of therapeutics, international regulatory affairs and clinical research, and epidemiology.
- Location: Washington, DC
- Accreditation: Middle States Commission on Higher Education (MSCHE)
- Expected Time to Completion: 14 months to two years
Arizona State University – Edson College of Nursing and Health Innovation
Aspiring clinical trial managers can complete an online master 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.
The curriculum includes coursework in responsible conduct of clinical research; fundamentals of regulatory affairs, clinical research operations, scientific and research review boards, clinical research data management and technology implementation, clinical research monitoring, clinical research design and methods, drug discovery, development, and regulations, global regulatory affairs leadership, healthcare project management, and quality assurance and clinical research.
To be eligible for admissions, candidates must hold a master’s or bachelor’s degree and complete coursework in anatomy, physiology, and medical terminology.
- Location: Phoenix, AZ
- Accreditation: Higher Learning Commission (HLC)
- Expected Time to Completion: 18 months to two years
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. The program is made up of 36 credits.
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 completing this program, students will be eligible to sit for the ACRP or SOCRA certification. This program is geared towards professionals who already work in this field, so two years of relevant work experience must be considered for admission. Other admission requirements include 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.
The seven key areas of study include new product research and development, ethics and law, compliance and safety surveillance, biostatistics and data management, regulatory affairs, new therapeutic product business and strategic planning, and clinical research management.
- Location: Philadelphia, PA
- Accreditation: Middle States Commission on Higher Education (MSCHE)
- Expected Time to Completion: Two to three years
Rutgers, The State University of New Jersey
Professionals in the 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.
Students must take two required classes: drug development from concept to market and drug discovery through preclinical development. They must also complete three elective courses in 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
- Accreditation: Middle States Commission on Higher Education (MSCHE)
- Expected Time to Completion: Two to three semesters
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 clinical trials process, roles and responsibilities; ethical and safety considerations; new product introduction, branding, and marketing; monitoring and oversight of clinical trials; data management and coding principles; and U.S. regulatory compliance.
This program is perfect for those looking to expand their knowledge or sit a certification exam. It is targeted at professionals already working in health care or clinical trials and offers discounts for military personnel, University of Delaware alumni, and early registration.
- Location: Newark, DE
- Accreditation: Middle States Commission on Higher Education (MSCHE)
- Expected Time to Completion: 14 weeks
University of Chicago – Graham School of Continuing Liberal and Professional Studies
With the online clinical trials management and regulatory compliance non-credit certificate at the University of Chicago Graham School of Continuing Liberal and Professional Studies, students will gain a keen understanding of the entire clinical trials process and the skills necessary to manage one. 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, statistical concepts for clinical research, good clinical practices, fundamentals of site management, and project management and leadership in the healthcare industry.
Admission requirements are easy to satisfy, with only a bachelor’s degree, a current resume or CV, and a personal statement being required.
- Location: Chicago, IL
- Accreditation: Higher Learning Commission (HLC)
- Expected Time to Completion: Nine months to three years
Wake Forest University – School of Medicine
Wake Forest University offers an online master of science degree in clinical research management that focuses on integrating patient care and clinical research. Graduates of the program will be prepared to bring innovative treatments to the market in a timely and cost-effective manner. Students in this program will learn in an engaging, innovative, interdisciplinary, and supportive online environment and will be trained to move the research and development process forward.
The knowledge and skills gained in this program can be applied to a range of biomedical fields. Upon completion, graduates will be well-prepared to work in the device, biotechnology, and pharmaceutical industries, government and private research labs, healthcare institutions, dedicated clinical research organizations, and academia.
The program allows students to choose between two tracks: strategic leadership/communications or operations. The 35-credit program includes 11 credits in foundational courses, 14 credits in core courses, four credits in concentration courses, and six credits for a capstone project. Courses include ethical and participant safety considerations, clinical studies development, data management and informatics, conflict resolution and negotiations, technical writing for the regulatory professional, and clinical operations and project management.
- Location: Winston-Salem, NC
- Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
- Expected Time to Completion: 20 months
Ohio State University – College of Nursing
Ohio State University offers an online graduate-level certificate in clinical research management. This 12-credit program includes courses such as responsible conduct of research, fundamentals of medical product development and regulation, clinical research study and site management, and project management for healthcare and clinical research. All credits earned in this program can be applied to Ohio’s existing master of clinical research program.
Offered entirely online, the CAAHEP-accredited master of clinical research program prepares students to excel as clinical research managers and coordinators, data and project managers, clinical research associates (monitors), regulatory compliance officers, clinical research trainers, research quality analysts, institutional review board specialists, and many other positions in the clinical research enterprise. Graduates will be eligible to sit for ACRP and SoCRA basic certifications.
This fully online master’s degree includes two specialization options in clinical research management and regulatory affairs.
- Location: Columbus, OH
- Accreditation: Higher Learning Commission (HLC); Commission on Accreditation of Allied Health Education Programs (CAAHEP)
- Expected Time to Completion: Certificate (three semesters); MCR (12 to 24 months)
How Long Does it Take to Become a Clinical Trials Manager?
Depending on the education level pursued, it can take four to seven or more postsecondary 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. Majors can include clinical trial 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 trial 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 the Association of Clinical Research Professionals (ACRP) and 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 trial staff
- Gathering and interpreting data
- Making changes to the trial structure based on the 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 2023), clinical trial managers are considered medical and health services managers. They earn $127,980 per year on average. The percentiles for wages are:
| United States | |
|---|---|
| Number employed in the U.S. | 515,100 |
| Average Annual Salary | $134,440 |
| 10th Percentile | $67,900 |
| 25th Percentile | $86,080 |
| 50th Percentile (Median) | $110,680 |
| 75th Percentile | $157,640 |
| 90th Percentile | $216,750 |
Clinical Trials Manager Career Alternatives
Here are a few alternatives to a career as a clinical trials manager
Become a Clinical Trial Principal Investigator
Principal investigators lead and conduct clinical trials. They lay the foundation for a successful trial and then rely on investigators, clinical trial managers, and other staff to help them succeed. They are also often responsible for administering 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
WriterAt HealthcareDegree.com, Kimmy Gustafson has delivered in-depth and insightful articles since 2019, aiding prospective students to navigate the complexities of choosing the right healthcare degree. Her recent work includes topics such as the ethics of gene editing and physician assistant’s fight for autonomy.
Kimmy has been a freelance writer for more than a decade, writing hundreds of articles on a wide variety of topics such as startups, nonprofits, healthcare, kiteboarding, the outdoors, and higher education. She is passionate about seeing the world and has traveled to over 27 countries. She holds a bachelor’s degree in journalism from the University of Oregon. When not working, she can be found outdoors, parenting, kiteboarding, or cooking.