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“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.”

“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.”

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.

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 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.

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.

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).

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

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)

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.

• Accreditation: Higher Learning Commission (HLC)

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.

• Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
• Expected Time to Completion: Two semesters

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. Incorporat