Job Profile: Clinical Trial Manager

In today’s ever-advancing medical field, clinical trials serve an essential purpose to determine if a type of medical treatment, device, or medication is safe and effective. To ensure the smooth operation and effectiveness of clinical trials, qualified professionals are essential. A clinical trial manager is responsible for directing the process of clinical trials by employing effective organizational strategies and reviewing the results using rigorous clinical procedures. He or she often interacts with clinical staff, reviews the progress of trials, and makes the necessary modifications to the structure and processes based on results or feedback. In all activities, a clinical trial manager must respect confidentiality and privacy and abide by safety standards.

Salary

According to Payscale.com, the average salary for clinical trial managers is $99,254. Actual yearly pay for these professionals varies depending on a variety of factors, such as location, employer, education, and experience.

Beginning Salary

The beginning salary for a clinical trial manager is around $65,761.

Key Responsibilities

The primary responsibility for a clinical trial manager is managing new and ongoing clinical trials. He or she is in charge of preparing protocols and case forms and finalizing monitoring and data management options. He or she is responsible for the development of recruitment methods to increase patient randomization into the trial, approval for trials from an ethics committee, delivery of materials for clinical trials, and coordinating the trial to make sure it runs smoothly. A clinical trial manager also trains, directs, and manages other professionals, such as clinical trial investigators, clinical trial nurses, and other clinical trial associates. He or she must make sure all individuals are up to date on all aspects of a clinical trial. A clinical trial manager also spends a great deal of time communicating with other professionals via phone, email, and face-to-face meetings to make sure the whole clinical trial team is consistently aware of any relevant information and issues.

Necessary Skills

A clinical trial manager must have the ability to work independently as well as communicate well with other professionals. He or she must have strong written and verbal communication abilities and highly effective interpersonal skills. He or she must also have the confidence to direct training sessions or present protocols, research findings, and trial results. Excellent organization and ability to focus on detail are also essential as all paperwork must be filed systematically and submitted to the appropriate individual or organization. A clinical trial manager must also possess effective leadership abilities.

Degree and Education Requirements

A minimum of a bachelor’s degree in life science or closely related field is the minimum requirement for individuals seeking to become a clinical trial manager. Those who complete a master’s degree in clinical research or a specialized certificate would be qualified for higher paid positions with advanced responsibilities. Specialized programs in clinical research often include courses in legal regulations, medical terminology, ethical issues, and clinical research databases. The Academy of Clinical Research Professionals offers a post bachelor’s degree certificate to become a clinical trial manager. The courses commonly include advanced training in clinical research writing, site management, drug development procedures, and statistical analysis. Some employers seek candidates with a post-baccalaureate certification. The Society for Clinical Data Management and the Society of Clinical Research Associates offer certification examinations. The certification examinations require at least a bachelor’s degree and two to four years of related work experience.

Pros and Cons of this Position

Working as a clinical trial manager has various positive aspects as well as challenges. Clinical trials provide individuals with promising new treatment methods that are not available otherwise, this is a rewarding aspect of giving new hope to those suffering from life threatening medical conditions. A clinical trial manager has the ability to combine an array of skills with scientific research to help develop new treatment methods, this is very rewarding and fulfilling to play a part in the advancement of medicine. This position features a high income potential and the ability to advance to upper level positions. In general, the clinical trial environment is comfortable. A major challenge is a clinical trial may not work or could have detrimental effects on patients and this is often emotionally taxing on medical professionals involved. The work environment can also become very stressful when issues arise, as a single mistake could pose significant effects on the entire trial. A clinical trial manager must always be on their toes to make sure there are zero defects in the clinical trial process. Also, extensive knowledge of government regulations is required and a clinical trial manager must always stay abreast of the additions and modifications to these regulations.

Getting Started

For those interested in becoming a clinical trial manager, they must first know what people in the position do. A great first step would be interviewing a current clinical trial manager and possibly shadowing them to get a solid understanding of what they do. Majority of employers of clinical trial managers prefer individuals who have significant experience in the field of clinical research. Aspiring clinical trial managers often begin their careers in other positions, such clinical research nurses, clinical research assistants, or clinical research associates. Others are employed in other areas of the medical field. Individuals must work hard to advance and demonstrate their capability to move into management positions. Many individuals participate in workshops and other practical experiences in clinical research.

Future Outlook

A clinical trial manager has the ability to work for an array of companies and organizations, including hospitals, pharmaceutical companies, government-based organizations, nongovernmental agencies, and clinical research organizations. After gaining significant experience as a clinical trial manager, many individuals go into project management where they oversee a team of associates. Other individuals move into director positions, such as a director of clinical research. As stated by the Bureau of Labor Statistics, the job growth for medical and health services managers is projected to increase must faster than the average for all professions, rising 17 percent by 2024. The job prospects are likely to be very favorable, especially for those with a master’s degree or above.

Clinical trials are essential to the healthcare industry in developing new treatment methods and medications for an array of medical conditions. A clinical trial manager plays such a key role and this is a rewarding and lucrative career for those who have a passion for making a difference.

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