Career Development

What Does a Clinical Trial Manager Do?

Find out what a clinical trial manager does, how to get this job, and what it takes to succeed as a clinical trial manager.

Clinical trial managers are responsible for overseeing the clinical trials that take place in their organization. They ensure that all protocols and procedures are followed, monitor the safety of all participants, and manage communications with regulatory agencies.

Clinical trial managers must have a strong understanding of medical research and how it’s conducted. They also need to be able to effectively communicate with all members of their team—from researchers to lab technicians to physicians—to ensure that everyone is on the same page about what needs to happen next.

Clinical Trial Manager Job Duties

Clinical trial managers typically have a wide range of responsibilities, which can include:

  • Ensuring that all staff members follow study protocols and maintain accurate records of their work activities
  • Ensuring that all records are kept confidential throughout the duration of the study
  • Educating patients about the study protocol, their rights as participants in a research study, and potential risks involved with participation
  • Coordinating with members of the research team to ensure that all study procedures are carried out properly
  • Coordinating with sponsors of research projects to ensure that study objectives are met
  • Preparing budgets, planning budgets, and managing budgets for clinical trials
  • Coordinating activities with investigators, research staff, health care providers, ethics committees, Institutional Review Boards, and other regulatory agencies involved in the study
  • Developing and implementing procedures and processes to ensure that studies run smoothly and efficiently
  • Overseeing the study from beginning to end to ensure that it is carried out in accordance with all regulations and that data is collected accurately

Clinical Trial Manager Salary & Outlook

Clinical trial managers’ salaries vary depending on their level of education, years of experience, and the size and industry of the company. They may also earn additional compensation in the form of bonuses.

  • Median Annual Salary: $125,000 ($60.1/hour)
  • Top 10% Annual Salary: $420,000 ($201.92/hour)

The employment of clinical trial managers is expected to grow faster than average over the next decade.

As pharmaceutical companies continue to conduct clinical trials for new drugs, demand for clinical trial managers will increase. Clinical trial managers will be needed to ensure that these trials are conducted in a safe and ethical manner.

Clinical Trial Manager Job Requirements

A clinical trial manager typically needs to have the following qualifications:

Education: Most employers require clinical trial managers to have a bachelor’s degree in a related field, such as health care, science or business. Some employers may hire candidates who have a related associate degree. Courses that clinical trial managers can take to prepare them for this role include research methods, ethics, statistics and research design.

Training & Experience: Clinical trial managers receive most of their training on the job. They may work as a clinical research assistant or a clinical research associate before advancing to clinical trial manager. Working as a clinical research assistant or associate provides them with the basic knowledge and skills to become a clinical trial manager.

Clinical trial managers can also receive additional training through conferences and seminars. These professionals can attend seminars and conferences to learn more about clinical trials and the latest regulations. They can also learn more about the latest software and technology that clinical trial managers use.

Certifications & Licenses: Certifications are not usually a requirement as a clinical trial manager, but they can help you become a more competitive candidate when applying for jobs.

Clinical Trial Manager Skills

Clinical trial managers need the following skills in order to be successful:

Communication: Clinical trial managers communicate with many people throughout their workday. They may communicate with research staff, volunteers, sponsors and other stakeholders. They also communicate with each other to share information and collaborate on projects. Effective communication skills can help clinical trial managers to be more efficient and productive.

Organization: Clinical trial managers use organization skills to keep track of multiple tasks and deadlines at once. They may also use organization skills to create schedules for their team and individual members. Organization skills can also help clinical trial managers keep track of research data and other important documents.

Time management: Time management is the ability to plan and execute tasks within a set time frame. Clinical trial managers use time management skills to ensure that their team meets deadlines and that the trial is progressing as planned. This can include scheduling meetings, reviewing data and making adjustments to the trial as needed.

Problem-solving: A clinical trial manager’s job involves managing a variety of tasks and responsibilities. They may be responsible for ensuring that the trial follows protocol, that the trial is on schedule and that the trial is within budget. A clinical trial manager may also be responsible for managing the team of people working on the trial. This job requires a variety of skills and talents, and problem-solving is an important one.

Critical thinking: Clinical trial managers use critical thinking to make decisions and solve problems. They may need to make quick decisions about how to proceed with a trial if an issue arises or if a participant experiences an adverse reaction. They may also need to think critically about how to best allocate resources and make decisions about which data to analyze.

Clinical Trial Manager Work Environment

Clinical trial managers work in a variety of settings, including hospitals, pharmaceutical companies, and research institutions. They typically work full time, and some may work more than 40 hours per week to meet deadlines or to coordinate with other team members who are in different time zones. Many clinical trial managers travel to attend conferences, meet with clients, or conduct site visits. The work can be stressful, and clinical trial managers must be able to handle multiple tasks simultaneously and work well under pressure. They must also be able to work independently and be self-motivated, as they may have to manage several projects at once with little supervision.

Clinical Trial Manager Trends

Here are three trends influencing how clinical trial managers work. Clinical trial managers will need to stay up-to-date on these developments to keep their skills relevant and maintain a competitive advantage in the workplace.

The Need for More Clinical Trial Managers

The need for more clinical trial managers is a trend that is being driven by the increasing complexity of clinical trials. As trials become more complex, there is a greater need for professionals who can manage them effectively.

Clinical trial managers are essential to the success of clinical trials, as they are responsible for overseeing all aspects of the trial from start to finish. By understanding the complexities of clinical trials and how to manage them, clinical trial managers can be extremely valuable assets to any company conducting clinical trials.

More Collaboration Between Regulatory and Clinical Teams

As clinical trials become more complex, there is an increasing need for collaboration between regulatory and clinical teams. This is because both teams are responsible for ensuring that clinical trials are conducted safely and ethically.

Clinical trial managers can take advantage of this trend by developing strong relationships with members of the regulatory team. This will allow them to work together to ensure that clinical trials are conducted according to the highest standards.

A Greater Focus on Patient-Centered Care

Patient-centered care has become increasingly important in recent years as healthcare providers have begun to focus on providing high-quality care that meets the needs of individual patients.

This trend is having a significant impact on the role of the clinical trial manager, who is now responsible for ensuring that patient-centered care is a top priority throughout the entire clinical trial process. Clinical trial managers must be able to communicate with patients and their families to understand what their needs are and how best to meet them. In addition, they must be able to track and monitor patient data to ensure that it is being used to improve the quality of care provided.

How to Become a Clinical Trial Manager

A clinical trial manager career can be a great way to use your medical knowledge and experience in a new way. As a clinical trial manager, you’ll work with researchers and scientists to plan and execute clinical trials that test the safety and effectiveness of new drugs and treatments.

This is a highly specialized field, so it’s important to have the right training and experience before starting a clinical trial manager career. You should also be comfortable working in a fast-paced environment and managing multiple projects at once.

Advancement Prospects

The clinical trial manager is responsible for the day-to-day management of a clinical trial. He or she works with the sponsor, principal investigator, and other members of the research team to ensure that the trial is conducted according to the protocol and in compliance with all applicable regulations. The clinical trial manager may also be responsible for the budget and for recruiting and training the trial staff.

As a clinical trial manager, you will have the opportunity to work on a variety of different types of trials, each with its own challenges. You may also have the opportunity to work on more than one trial at a time. With experience, you may be promoted to a senior position, such as director of clinical trials or vice president of clinical research.

Clinical Trial Manager Job Description Example

The [CompanyX] team is looking for a highly-organized and detail-oriented clinical trial manager to help us with the development and implementation of our clinical trials. The ideal candidate will have experience working in a clinical research setting, and will be responsible for the day-to-day management of our clinical trials. This includes working with our team of investigators to develop protocols, ensuring that our trials are conducted in accordance with Good Clinical Practices, and coordinating with our sponsors and CROs. The clinical trial manager will also be responsible for tracking our progress and communicating our results to the appropriate parties.

Duties & Responsibilities

  • Serve as the primary contact for assigned clinical studies, ensuring that all aspects of the trial are conducted in accordance with protocol, Standard Operating Procedures (SOPs), ICH/GCP guidelines, and applicable regulations
  • Develop and maintain strong relationships with study sponsors, monitors, and other external partners to ensure successful clinical trial execution
  • Oversee the development and implementation of clinical study plans, timelines, and budgets in collaboration with cross-functional team members
  • Identify and track project risks and issues, developing and implementing mitigation strategies as needed
  • Monitor clinical sites to ensure adherence to study protocols and completion of required documentation
  • Review and approve site monitoring visit reports
  • Serve as a resource to study sites on protocol-related questions and issues
  • Manage the collection, review, and reporting of clinical data, ensuring accuracy and completeness
  • Prepare and submit clinical study reports to sponsors
  • Participate in audits and inspections by sponsors, monitors, and regulatory agencies
  • Stay abreast of new developments in clinical research and regulations
  • Train and mentor junior staff members

Required Skills and Qualifications

  • Bachelor’s degree in a scientific discipline
  • 5+ years experience managing clinical trials
  • Working knowledge of FDA regulations governing clinical trials
  • Excellent communication, interpersonal, and organizational skills
  • Ability to work independently and as part of a team
  • Proficient in Microsoft Office, with aptitude to learn new software and systems

Preferred Skills and Qualifications

  • Master’s degree or higher in a scientific discipline
  • 7+ years experience managing clinical trials
  • Experience working with an electronic data capture system
  • Familiarity with Good Clinical Practices (GCP) guidelines
  • Knowledge of medical terminology

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