Clinical research managers hold one of the most critical jobs in the healthcare industry, overseeing all aspects of clinical trials that evaluate new medications and medical devices.
People in these positions carry the responsibility for making sure the trial is conducted under very strict, very specific guidelines.
The job carries a great deal of responsibility. Clinical trials are a vital part of the development of any new medication or medical device, and companies often have their future riding on the outcome. Clinical trial managers not only oversee the trial, but also act as liaison between the trial site and the clinical study sponsor.
It’s a difficult job, but one that can provide a rewarding, stable and often lucrative career.
What Clinical Research Managers Do
When a company develops a new healthcare product, they must meet government regulations before being allowed to sell their product on the market. This means conducting clinical trials that determine whether the product does what its developers say it’s going to do, as well as ensuring that the product is safe for use.
Clinical research managers have a variety of duties associated with such trials. They include:
- Planning and overseeing the trial
- Determining whether a product accomplishes the goal for which it was produced
- Ensuring the product meets all government regulations and standards
- Managing a team of clinical research associates and specialists
- Training clinical research team members and evaluating their performance
In addition, clinical research managers communicate with trial sponsors, keeping them updated on progress.
Skills and Education Needed
Working as a clinical research manager requires a mix of skills. They include leadership in guiding the research team, communication skills with both the team and study sponsors, as well as the technical skills needed to successfully plan and execute a clinical trial.
The people in this field come from various backgrounds. They typically have at least a bachelor’s degree in a field related to their clinical work, ranging from biology to life sciences and bioengineering. Attaining the manager position almost always requires a master’s degree or doctorate.
The ability to write study protocols and other research-related documents is key, as is expert-level knowledge in clinical trial practices and regulations. Project management skills also can prove beneficial for clinical research managers, given the complexity of the job and requirement to lead cross-functional teams.
Typically, those who become research managers also have years of experience at lower levels of the operation, including research specialists.