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What is a Clinical Trial Manager?

A clinical trial manager is a person that implements, supervises, and carries out clinical trials. This is a demanding role as many different research companies and organizations rely on the accuracy and outcome of these trials. This is the only way a new product or drug can be approved for use.

What do Clinical Trial Managers do?

Clinical trials are case studies on many individuals to see if a new treatment, vaccine, product, procedure, or drug, for example, is effective. The trials also include research done to determine whether a new technique, piece of equipment, or drug is safe. Some clinical trials are used for preventative medicine. For example, a trial may be executed to determine if a disease or chronic condition can be discovered earlier.

The clinical trial manager makes sure that the trials are carried out within budget, time constraints, and are up to standard. There are many strict regulations and processes to abide by to make sure the trial itself is acceptable. They also are responsible for monitoring and documenting the process as well as working with both the sponsor of the product and the trial site.

There are four different phases of clinical trials. The first three determine if the drug or vaccine, for example, is effective and safe. After the third trial, the Food and Drug Administration or determining factor will approve the drug or products. The fourth trial is monitoring the effectiveness and side effects over a period of time.

Other responsibilities of a clinical trial manager may include researching, writing, staffing, and implementing the protocols. They also must monitor the quality of the trials and make sure staff is adhering to the guidelines.  They will be responsible for creating budgets for each trial and for finding acceptable participants. They must make sure they have the right amount of participants and be able to reevaluate and make adjustments when necessary.

Managers learn and abide by certain ethics, legalities, and operating procedures. They must ensure the staff and participants do as well.

Throughout the trials and when trials are completed the manager will have compiled detailed data and created reports outlining the trial and the results.

Where do Clinical Trial Managers work?

People in this field tend to work at universities, hospitals, pharmaceutical companies, government-based organizations, or other private research centers. There is now also some opportunity to be a remote clinical trial manager.

What degree is required for a Clinical Trial Manager?

Typically a manager has a bachelor’s degree in a field of study that correlates with the type of clinical trials they will be managing. Most likely the degree is in biology, chemistry, medicine, pharmacy, life sciences, bioengineering, or other science-related work.

Though this is not required most candidates have a master’s degree or a doctorate in one of these fields. According to a study from North Carolina State University, about fifty percent of jobs require a bachelor’s degree and another fifty percent also require a doctorate. Many online accreditation programs may facilitate work into positions such as a Post Graduate Diploma in Clinical Trials or Clinical Research. Many people will have worked previously as a research specialist or another job involved with the trials themselves.

How much money does a Clinical Trial Manager earn?

This can be a very lucrative career and just like anything the more skills you have, the more experience under your belt the more money can be made. According to PayScale, The base rate for a clinical trial manager starts around at $67,000 per year and can be upwards of $147,000 per year.

If you have expertise in oncology, team management, clincial research, operations, or team management, the payscale seems to start closer to $100,000 per year.

Clinical Trial Manager Job Requirements

This job requires great leadership and communication skills to guide the staff, participants research team, and sponsors. It requires having a great understanding of the technical knowledge for a trial to be executed and successful. Exceptional writing skills to explain the process, reasons, and outcomes of a trial are crucial. It is also important to be able to accurately document and record information.

The ability to write protocols that adhere to legal and federal guidelines is also essential. These guidelines include following ethical rules and outlines, accurate reporting, and ensuring subjects included in the trials are protected and are aware of their rights and risks as they take part in the trial.

Clinical Trial Manager Career Path

A clinical trial manager is a great jumping-off point. Opportunity for advancement includes positions such as a clinical operations manager, a clinical project manager, or a general project manager. A clinical operations manager is somebody that oversees a medical facility. A clinical project manager evaluates clinical trial data. They are typically senior to the clinical trial manager. A general project manager oversees a project but can be connected to any other field, not just healthcare and science.

The position of clinical operations manager can also lead to becoming a Director of Operations. A Director of Operations manages the day-to-day operations, the resources and the facility itself. This position is a step up from the clinical operations manager.

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Senior Staff Breast Imager Henry Ford Health Michigan US 04/25/2024
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