What does a Clinical Research Manager do?
A clinical research manager is responsible for leading a clinical research team in conducting clinical trials for medical purposes. Clinical research managers conduct scientific investigations, following critical methods and procedures within the budget goals and discussed timeframe. They monitor the adequacy of laboratory tools and equipment, request purchase orders, and ensure the authenticity of the materials for the accuracy of findings. A clinical research manager also enforces strict safety standards and protocols during clinical trials to avoid potential hazards and chemical contamination.
Clinical research manager responsibilities
Here are examples of responsibilities from real clinical research manager resumes:
- Launch and manage a regional CRA monitoring group that grow to 100 plus staff in two years.
- Manage all planning and execution of oncology clinical trials, domestic and international, including decision impact and companion diagnostic trials.
- Prepare applications to have studies approve by hospital's institutional review board (IRB) and help present study to IRB.
- Develop an open access communication method for patients to discuss their questions and/or concerns with the principal investigators.
- Major contributor to the NDA for both Depo-Provera contraceptive as well as Caverject for erectile dysfunction.
- Interview, select, train, and monitor all clinical sites; negotiate site and CRO budgets.
- Deliver strong understanding of the clinical research process and its components, including fundamental knowledge of current regulations and GCP.
- Ensure that the investigator and research staff perform the specified trial functions according to the study protocol and follow GCP guidelines
- Contract management of issues relate to the sites and budgets as well as contract management reviews of vendor and CRO's.
- Contribute in obtaining and updating all site-specific study requirements including IRB submissions, updates and revision.
- Work with legal and regulatory on FDA regulations/ICH guidelines regarding conduct of clinical studies for investigator initiate programs.
- Extract data and medical information from medical records and laboratory reports and enter respective data into CRF database.
- Prepare for and guide coordinators, medical directors, and investigators during FDA audits and sponsor initiate quality assurance audits.
- Manage all planning and execution of oncology clinical trials, domestic and international, including decision impact and companion diagnostic trials.
- Implement and analyze QA in accordance with institutional and national standards.
Clinical research manager skills and personality traits
We calculated that 9% of Clinical Research Managers are proficient in Patients, Oversight, and FDA. They’re also known for soft skills such as Communication skills, Interpersonal skills, and Leadership skills.
We break down the percentage of Clinical Research Managers that have these skills listed on their resume here:
- Patients, 9%
Developed an open access communication method for patients to discuss their questions and/or concerns with the principal investigators.
- Oversight, 8%
Provide project management and oversight of pharmaceutical company sponsored clinical research trials conducted in physician office.
- FDA, 5%
Prepared for and guided coordinators, medical directors, and investigators during FDA audits and sponsor initiated quality assurance audits.
- IRB, 5%
Created and managed regulatory documentation while performing all IRB Submissions.
- Project Management, 5%
Partner with Project Management and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business processes.
- Data Management, 4%
Monitored multiple research studies, ensured regulatory integrity and compliance of research activities study supplies and clinical data management.
Common skills that a clinical research manager uses to do their job include "patients," "oversight," and "fda." You can find details on the most important clinical research manager responsibilities below.
Communication skills. One of the key soft skills for a clinical research manager to have is communication skills. You can see how this relates to what clinical research managers do 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 research manager resume shows how clinical research managers use communication skills: "oversee compliance, communication with the irb, fda, sponsors, maintenance of regulatory documentation, conducting internal audits. "
Interpersonal skills. Another essential skill to perform clinical research manager duties is interpersonal skills. Clinical research 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 research 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 research managers to perform their duties. For an example of how clinical research 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 research manager: "provided leadership and direction to research program staff including research managers, cras and registry associates. ".
Problem-solving skills. clinical research manager responsibilities often require "problem-solving skills." The duties that rely on this skill are shown by the fact that "natural sciences managers use scientific observation and analysis to find answers to complex technical questions." This resume example shows what clinical research managers do with problem-solving skills on a typical day: "perform data entry, creating data queries and following through resolution for all studies. "
Time-management skills. Another crucial skill for a clinical research manager to carry out their responsibilities is "time-management skills." A big part of what clinical research managers relies on this skill, since "natural sciences managers must be able to perform multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule." How this skill relates to clinical research manager duties can be seen in an example from a clinical research manager resume snippet: "supervised 60 team members on a daily basis to complete research projects within deadlines. "
The three companies that hire the most clinical research managers are:
- ICF53 clinical research managers jobs
- Columbia University in the City of New York14 clinical research managers jobs
- Children's Hospital Colorado13 clinical research managers jobs
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Compare different clinical research managers
Clinical research manager vs. Assistant director of nursing
An assistant director of nursing is responsible for administering quality care services for patients, supervising nursing activities, and ensuring the patients' comfort under the supervision of the director of nursing. Assistant directors of nursing assist with nursing staff training, distributing shift schedules, developing comprehensive nursing care plans, handling expense reports, identifying areas of improvement with the staff performance, and securing patients' medical charts for reference. An assistant director of nursing must have excellent communication and organizational skills, especially in handling patients' medical needs.
These skill sets are where the common ground ends though. The responsibilities of a clinical research manager are more likely to require skills like "fda," "irb," "project management," and "data management." On the other hand, a job as an assistant director of nursing requires skills like "term care," "cpr," "quality care," and "resident care." As you can see, what employees do in each career varies considerably.
Assistant directors of nursing really shine in the manufacturing industry with an average salary of $85,610. Comparatively, clinical research managers tend to make the most money in the pharmaceutical industry with an average salary of $95,183.On average, assistant directors of nursing reach lower levels of education than clinical research managers. Assistant directors of nursing are 14.8% less likely to earn a Master's Degree and 7.3% less likely to graduate with a Doctoral Degree.Clinical research manager vs. Study director
Technically, a study director carries out scientific responsibilities for protocol design or study plan and approval. Study directors supervise the gathering, analysis, interpretation, documentation, and reporting of data results. They handle the matriculation of students with regard to data management system development. Working with the computer systems team is part of their duties so they will be able to establish a data management system in tracking the study participants. They also support the toxicology team or group on different project teams.
In addition to the difference in salary, there are some other key differences worth noting. For example, clinical research manager responsibilities are more likely to require skills like "patients," "oversight," "data management," and "patient care." Meanwhile, a study director has duties that require skills in areas such as "toxicology," "data interpretation," "laboratory practices," and "chemistry." These differences highlight just how different the day-to-day in each role looks.
On average, study directors earn a lower salary than clinical research managers. Some industries support higher salaries in each profession. Interestingly enough, study directors earn the most pay in the health care industry with an average salary of $87,246. Whereas clinical research managers have higher pay in the pharmaceutical industry, with an average salary of $95,183.Average education levels between the two professions vary. Study directors tend to reach similar levels of education than clinical research managers. In fact, they're 2.0% less likely to graduate with a Master's Degree and 7.3% more likely to earn a Doctoral Degree.Clinical research 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 research managers are more likely to have skills like "patients," "oversight," "fda," and "data management." But a senior program coordinator is more likely to have skills like "alumni," "excellent organizational," "powerpoint," and "sr."
When it comes to education, senior program coordinators tend to earn similar degree levels compared to clinical research managers. In fact, they're 4.7% less likely to earn a Master's Degree, and 6.5% less likely to graduate with a Doctoral Degree.Clinical research manager vs. Study coordinator
Study coordinators oversee the entire process of clinical research from its inception to its completion. The coordinators make certain that human subjects are safe and well-protected. They identify the eligibility of the subject through clinical record screening and medical information extracting. It is their responsibility to maintain the regulatory documents based on the requirements of the Food and Drug Administration (FDA). They should develop skills and knowledge in clinical trials, study protocol, and patient care.
Even though a few skill sets overlap between clinical research managers and study coordinators, there are some differences that are important to note. For one, a clinical research manager might have more use for skills like "oversight," "project management," "research projects," and "principal investigators." Meanwhile, some responsibilities of study coordinators require skills like "clinical trials," "research data," "excellent interpersonal," and "medical history. "
In general, study coordinators earn the most working in the health care industry, with an average salary of $50,589. The highest-paying industry for a clinical research manager is the pharmaceutical industry.The average resume of study coordinators showed that they earn lower levels of education compared to clinical research managers. So much so that theyacirc;euro;trade;re 5.2% less likely to earn a Master's Degree and less likely to earn a Doctoral Degree by 4.4%.Types of clinical research manager
Updated January 8, 2025
