How to Become a Clinical Trial Manager.
Clinical research fuels innovation in the healthcare industry. Within the field of public health, clinical trials rest at the heart of the research process. During a clinical trial, medical researchers work closely with research participants, which may include both healthy volunteers and those with an illness or chronic condition, to test new treatment methods and evaluate the results.
Clinical trial managers are responsible for overseeing the day-to-day operations of clinical trials, positioning them at the forefront of discovery and innovation. It’s a position that requires an advanced understanding of the public health landscape, clinical experience, and extensive research skills. Anyone interested in this role will need to prioritize professional development and lifelong learning throughout their career.
What Does a Clinical Trial Manager Do?
A clinical trial manager oversees all stages of a clinical trial. This includes recruiting patient participants, developing protocols, creating data collection strategies, and ensuring accurate reporting. They also have to manage budgets for the clinical trial, establish a realistic and achievable timeline, and develop cross-functional teams to make the trial as seamless as possible.
In addition to overseeing day-to-day operations, clinical trial managers are responsible for making sure that all elements of the trial are in compliance with both regulatory requirements and ethical standards.
As leaders in the medical research field, clinical trial managers must be able to effectively collaborate with a variety of professionals, including principal investigators, data analysts, and sponsors. This requires a range of soft skills, including creative thinking, innovation, problem-solving, and data-driven analysis.
Where Clinical Trial Managers Work
While the job responsibilities of clinical trial managers are similar, regardless of their place of employment, they can work in a variety of settings. These may include:
- Pharmaceutical Companies — Pharmaceutical companies frequently conduct clinical research to verify the efficacy of new treatments and drugs that they are producing.
- Contract Research Organizations (CROs) — Contract research organizations, or CROs, are organizations hired by research centers to oversee clinical research within their facilities.
- Hospitals and Academic Institutions — Hospitals and universities often fund their own research projects to test treatment options and develop strategies for specific patients.
- Government Agencies — Government agencies, such as the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration, often conduct their own clinical research.
Becoming a Clinical Trial Manager
Health professionals who are passionate about clinical research and who have adept project management skills are well-suited to this role. There are a few key steps to getting started in this profession:
Education Steps
Clinical trial managers will have an extensive background in healthcare, research, and public health. While the specific requirements may vary, this is the educational track that is generally recommended:
Earn a bachelor’s degree in life sciences, nursing, public health, or a related field.
Pursue a master’s degree, as most organizations prefer clinical trial managers to have a graduate education. An Online Master of Public Health (OMPH), master’s in clinical research, or master’s in health administration are recommended. Even if a master’s degree is not required for a certain position, it may be needed to advance into leadership positions or earn a higher salary.
Pursue optional certifications to differentiate yourself in the job market. Top options include certified clinical research professional (CCRP) or certified clinical research coordinator (CCRC).
Master the Essential Skills
At one moment, a clinical trial manager may be working with a patient to provide them with personalized support; in another, they might be collaborating with the sponsor of the trial to deliver actionable insights based on recent data. No two days are alike for clinical trial managers, which means they need practical, technical, and soft skills to navigate this dynamic position.
The technical skills that clinical trial managers need to master include:
Research design and biostatistical skills. Clinical trial managers should ensure that the participant pool accurately reflects the patient population.
Data management and analysis. Clinical trial managers must oversee data collection and analysis efforts to generate accurate and insightful reports.
Regulatory knowledge. Clinical trial managers must be aware of all Food and Drug Administration (FDA), Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) guidelines and requirements.
Clinical data systems skills. Clinical trial managers must be familiar with electronic data capture (EDC) software.
As mentioned earlier, clinical trial managers also need a well-developed set of soft skills. These include leadership and communication abilities, project management skills, and strong problem-solving and critical thinking competencies.
Gain Clinical Research Experience
The clinical trial manager role requires extensive experience. Most clinical trial managers take on roles such as clinical research coordinator (CRC), clinical research associate (CRA), or research assistant before they pursue opportunities as a clinical trial manager.
Internship opportunities, volunteer work, and entry-level positions in hospitals and pharmaceutical research give candidates the ability to develop an advanced understanding of the modern healthcare landscape. They also gain unique insights into the needs of patients and the social determinants of health that affect patient outcomes.
Through hands-on experience, you can become more familiar with trial protocols and compliance standards, giving you a strong foundation to build upon as you work toward becoming a clinical trial manager.
Advance Into Management Roles
Once you have established a strong background through entry-level positions and external experiences, you can begin to advance into management roles that can prepare you for clinical trial manager positions. Experience as a CRA or study lead can open the door to management opportunities, where you’ll mentor junior staff, manage department budgets, and oversee multi-site studies. With a graduate education, such as an online MPH, you may be able to accelerate your career trajectory and earn those promotions sooner.
Explore the Role of a Clinical Trial Manager at Boston University
Clinical trial management plays a pivotal role in the evolving field of public health, as public health leaders, medical researchers, and healthcare providers collaborate to provide patients with the best possible treatment options. Both the On-Campus MPH and Online MPH at Boston University equip students with the real-world skills required to address the most pressing challenges in public health today. Graduates are positioned to pursue a wide range of job opportunities, including clinical trial manager positions.
Learn more about our online MPH and discover our commitment to online MPH student success.