What is a clinical study manager and how to become one

Updated January 8, 2025

4 min read

Quoted expert

Sharolyn Kawakami-Schulz Ph.D.

A clinical study manager plans, executes, and finalizes clinical trials. They oversee the entire process, including preparing protocols, recruiting volunteers, and managing budgets and timelines. Clinical study managers work with regulatory affairs specialists, data managers, and statisticians. They ensure compliance with relevant regulations, such as Good Clinical Practice (GCP), and validate that the data collected remains accurate and complete. Overall, clinical study managers contribute to the development of new drugs and medical devices through clinical trials.

What's a day at work look like for a clinical study manager?

Sharolyn Kawakami-Schulz Ph.D.

Director, Office of Professional Development, University of Minnesota Medical School

As the workforce continues to adapt to restrictions resulting from the pandemic, graduates can expect to find more workplaces discussing hybrid workdays, with a combination of in person and work from home activity. In some sectors, the pandemic has demonstrated that remote work can be a new normal. As graduates work across various sectors and in a variety of types of roles, each person's day will look different. However, flexibility and adaptability will continue to be key skills for success.

ScoreClinical Study ManagerUS Average

Salary

6.1

Avg. Salary $78,195

Avg. Salary $59,228

Stability level

5.6

Growth rate 6%

Growth rate 0.3%

Diversity

5.0

Race

American Indian and Alaska Native 0.51%

Asian 10.82%

Black or African American 2.57%

Hispanic or Latino 15.17%

Unknown 7.58%

White 63.34%

Gender

female 65.00%

male 35.00%

Age - 43.5

Race

American Indian and Alaska Native 3.00%

Asian 7.00%

Black or African American 14.00%

Hispanic or Latino 19.00%

White 57.00%

Gender

female 47.00%

male 53.00%

Age - 43.5

Stress level

5.6

Stress level is manageable

7.1 - high

Complexity level

8.5

Complexity level is advanced

7 - challenging

Work life balance

6.3

Work life balance is fair

6.4 - fair

What are the pros and cons of being a clinical study manager?

Pros

High level of responsibility and autonomy
Collaborative work with interdisciplinary teams
Competitive salary and benefits
Flexibility in work schedule and location
Varied work tasks and responsibilities

Cons

High level of stress and pressure to meet deadlines
Long working hours, including evenings and weekends
Risk of failure or negative outcomes in clinical trials
Limited ability to control study outcomes due to external factors such as patient recruitment or unexpected events
Challenging communication with patients, investigators, and sponsors

Key steps to become a clinical study manager

Explore clinical study manager education requirements

Most common clinical study manager degrees

Bachelor's

63.3 %

Master's

18.5 %

Associate

7.4 %

Start to develop specific clinical study manager skills

Skills	Percentages
GCP	7.18%
Informed Consent	6.73%
Oversight	6.49%
Clinical Operations	5.84%
ICH	5.70%

Complete relevant clinical study manager training and internships

Accountants spend an average of 6-12 months on post-employment, on-the-job training. New clinical study managers learn the skills and techniques required for their job and employer during this time. The chart below shows how long it takes to gain competency as a clinical study manager based on U.S. Bureau of Labor Statistics data and data from real clinical study manager resumes.

Research clinical study manager duties and responsibilities

Lead CRA training for Latin American, Asian and European to review GCP and protocol training.
Manage projects relate to commercialization and post market analysis for abdominal aortic aneurysm repair grafts as guided by FDA regulations.
Participate in CRF (EDC) design and CCG preparation.
Assist patients who suffer from depression, bipolar mood disorders, mental retardation, schizophrenia, post-traumatic disorder.

Prepare your clinical study manager resume

When your background is strong enough, you can start writing your clinical study manager resume.

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