What does a clinical study manager do?
A clinical study manager is primarily in charge of overseeing the efforts in conducting clinical studies, ensuring everything runs smoothly and efficiently. Their responsibilities include setting objectives, organizing budgets and schedules, establishing guidelines, delegating tasks, and developing strategies to optimize operations. They must also monitor the progress of the studies, conducting corrective measures when needed. Furthermore, as a clinical study manager, it is essential to lead and coordinate the workforce to reach goals, all while implementing the company's policies and regulations, including the study's vision and mission.
Clinical study manager responsibilities
Here are examples of responsibilities from real clinical study manager resumes:
- 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.
- Contact patients regarding study information.
- Develop study documents and facilitate IRB approvals.
- Coordinate clinical protocol development and CRF design.
- Facilitate compliance with the requirements of oncology research protocols.
- Maintain drug accountability, protocol compliance and FDA regulatory compliance.
- Prepare IRB and other regulatory documentation for site start-up activities.
- Perform evaluations of CRO performance via co-monitoring visits, and document in co-monitoring visit reports.
- Recommend and successfully transition a study from a CRO back in-house for significant operational cost savings.
- Recruit investigators perform pre-study visits, negotiate budgets, initiate and monitor studies and verify data for accuracy and completeness.
- Designed/Implemented/Monitore phase III/IV HIV clinical trial (Combivir/Abacavir).
- Perform routine laboratory maintenance and document procedures in accordance with GLP guidelines.
Clinical study manager skills and personality traits
We calculated that 7% of Clinical Study Managers are proficient in GCP, Informed Consent, and Oversight. They’re also known for soft skills such as Communication skills, Interpersonal skills, and Leadership skills.
We break down the percentage of Clinical Study Managers that have these skills listed on their resume here:
- GCP, 7%
Planed, tracked, and conduct follow-up on all site GCP audits, and vendor audits as required.
- Informed Consent, 7%
Negotiated and edited informed consent documents directly with the investigator site staff at multiple US oncology centers.
- Oversight, 6%
Delivered oversight of patient recruitment and retention efforts of country offices.
- Clinical Operations, 6%
Led study conduct and study monitoring team in clinical operations activities.
- ICH, 6%
Adhered to and complied with internal SOP's, ICH Guidelines and Good Clinical Practice.
- Data Management, 5%
Performed data management and clinical review of patient data and address discrepancies using Integrated Review and Oracle Clinical databases.
"gcp," "informed consent," and "oversight" are among the most common skills that clinical study managers use at work. You can find even more clinical study manager responsibilities below, including:
Communication skills. The most essential soft skill for a clinical study manager to carry out their responsibilities is communication skills. This skill is important for the role because "natural sciences managers must be able to communicate clearly with a variety of audiences, such as scientists, policymakers, and the public." Additionally, a clinical study manager resume shows how their duties depend on communication skills: "managed, maintained and updated study timelines to meet company targets through team communication, review of deliverables and resource management. "
Interpersonal skills. Another essential skill to perform clinical study manager duties is interpersonal skills. Clinical study managers responsibilities require that "natural sciences managers lead research teams and therefore need to work well with others in order to reach common goals." Clinical study managers also use interpersonal skills in their role according to a real resume snippet: "based on depth of experience and superb interpersonal skills, selected to train and mentor new clinical trials specialists. "
Leadership skills. This is an important skill for clinical study managers to perform their duties. For an example of how clinical study manager responsibilities depend on this skill, consider that "natural sciences managers must be able to organize, direct, and motivate others." This excerpt from a resume also shows how vital it is to everyday roles and responsibilities of a clinical study manager: "participated in advanced leadership training participated in advanced clinical trial management and resource training completed advanced oncology training".
Problem-solving skills. For certain clinical study manager responsibilities to be completed, the job requires competence in "problem-solving skills." The day-to-day duties of a clinical study manager rely on this skill, as "natural sciences managers use scientific observation and analysis to find answers to complex technical questions." For example, this snippet was taken directly from a resume about how this skill applies to what clinical study managers do: "communicate with clients in regards to study updates, scope changes, deviations, study issue resolution and study timelines. "
Time-management skills. A commonly-found skill in clinical study manager job descriptions, "time-management skills" is essential to what clinical study managers do. Clinical study manager responsibilities rely on this skill because "natural sciences managers must be able to perform multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule." You can also see how clinical study manager duties rely on time-management skills in this resume example: "managed over 25 clinical projects, all of which were successfully completed on time and with the highest quality. "
The three companies that hire the most clinical study managers are:
- Regeneron15 clinical study managers jobs
- Merck6 clinical study managers jobs
- Sanofi US5 clinical study managers jobs
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Compare different clinical study managers
Clinical study manager vs. Research nurse
A research nurse specializes in conducting studies and scientific research for healthcare and medical development. They may work for medical facilities, private clinics, learning institutions, and government agencies. It is their duty to design research strategies and procedures, gather and analyze samples through various scientific methods, coordinate with other experts, and develop treatment and healthcare plans to optimize patient services and outcomes. Moreover, a research nurse typically works with a team of researchers, which requires an active communication line while adhering to the organization's policies and regulations.
These skill sets are where the common ground ends though. The responsibilities of a clinical study manager are more likely to require skills like "oversight," "clinical operations," "study management," and "cro." On the other hand, a job as a research nurse requires skills like "oncology," "research projects," "clinical care," and "human subjects." As you can see, what employees do in each career varies considerably.
Research nurses really shine in the pharmaceutical industry with an average salary of $61,182. Comparatively, clinical study managers tend to make the most money in the manufacturing industry with an average salary of $83,613.On average, research nurses reach lower levels of education than clinical study managers. Research nurses are 5.9% less likely to earn a Master's Degree and 3.2% less likely to graduate with a Doctoral Degree.Clinical study manager vs. Research project coordinator
Research Project Coordinators take on a lead role in maintaining and creating processes that support the execution of a research project. Their duties include researching governance requirements, preparing for contract bidding, manage budgeting of a project to meet a specified timeline, and present findings of a project to all stakeholders involved. The Research Project Coordinator will also support administrative tasks, including producing corporate reports, organizing committee meetings, and developing a research database to track active milestones achieved.
In addition to the difference in salary, there are some other key differences worth noting. For example, clinical study manager responsibilities are more likely to require skills like "oversight," "clinical operations," "ich," and "study management." Meanwhile, a research project coordinator has duties that require skills in areas such as "project management," "public health," "data analysis," and "research study." These differences highlight just how different the day-to-day in each role looks.
Research project coordinators earn a lower average salary than clinical study managers. But research project coordinators earn the highest pay in the professional industry, with an average salary of $50,025. Additionally, clinical study managers earn the highest salaries in the manufacturing with average pay of $83,613 annually.In general, research project coordinators achieve similar levels of education than clinical study managers. They're 2.9% more likely to obtain a Master's Degree while being 3.2% less likely to earn a Doctoral Degree.Clinical study manager vs. Senior program coordinator
A senior program coordinator is primarily in charge of spearheading and managing programs, ensuring everything runs smoothly and efficiently. Their responsibilities revolve around participating in setting goals and objectives, securing funding and sponsors, overseeing the workforce, and even establishing guidelines. They may also facilitate communication within the company and liaise with external parties. Furthermore, as a senior program coordinator, it is essential to lead and encourage the teams to reach goals, all while implementing the company's policies and regulations, including its vision and mission.
The required skills of the two careers differ considerably. For example, clinical study managers are more likely to have skills like "gcp," "oversight," "clinical operations," and "ich." But a senior program coordinator is more likely to have skills like "alumni," "excellent organizational," "powerpoint," and "sr."
Senior program coordinators typically earn similar educational levels compared to clinical study managers. Specifically, they're 0.2% less likely to graduate with a Master's Degree, and 3.1% less likely to earn a Doctoral Degree.Clinical study manager vs. Coordinator and research assistant
Types of clinical study manager
Updated January 8, 2025
