Clinical Research Manager Job Description

Clinical Research Manager Job Description, Skills, and Salary

Get to know about the duties, responsibilities, qualifications, and skills requirements of a clinical research manager. You can use our job description template in this article to produce your own. We also provide you with information about the salary you can earn as a clinical research manager.

 

Who is a Clinical Research Manager?

A clinical research manager is an expert who plans, oversees, or participates in a clinical research project. These professionals handle all aspects of data collecting and analysis, ensure that all studies are conducted in line with ethical standards, and monitor the progress of each trial to ensure that it accomplishes its stated aims. The ultimate goal of a clinical research manager is to ensure that these trials are conducted efficiently and ethically while also providing pertinent data that can be used to improve patient care.

Clinical research managers may also be responsible for recruiting patients for clinical trials. To do this, it may be necessary to identify prospective participants through advertisements or other means, assess their suitability, and schedule appointments with the study coordinators or researchers so that they can conduct interviews or engage in other interactions.

 

Clinical Research Manager Job Description

Below are the clinical research manager job description examples you can use to develop your resume or write a job description for your employee. Employers can also use it to sieve out job seekers when choosing candidates for interviews.

The duties and responsibilities of a clinical research manager include the following:

  • Examining methods to ensure that they comply with moral standards and legal requirements.
  • Overseeing the recruitment of other research participants
  • Working with marketing staff to Promote study participation and coordinating with researchers and other team members to ensure that research activities are carried out effectively.
  • Adhering to the regulations defining the research participants’ eligibility criteria in light of their health state, demographics, and other pertinent characteristics.
  • Overseeing the development and completion of clinical research projects, including budgeting, IRB submissions, and legal compliance.
  • Developing close ties with key people and other members of the medical and scientific communities to promote study enrolment.
  • Managing the staff involved in clinical research, providing guidance and mentoring to ensure top performance and career advancement.
  • Ensuring that all data acquired for a study is accurate, complete, and following the law.
  • Examining research designs and protocols to ensure they follow ethical standards and scientific considerations.
  • Tracking the development of the study by reviewing information and reports from the research team.
  • Examining data from clinical trials to look for trends or problems with study design or results.
  • Generating reports on how research findings affect clinical practice.
  • Reviewing and approving invoices for payments related to clinical research initiatives.
  • Participating in audits and inspections conducted by regulatory agencies, CROs, and sponsors.

 

Qualifications

The qualifications of clinical research managers include the following:

  • A bachelor’s degree in a scientific field.
  • 5+ years of experience in clinical research, with at least three years in management.
  • Thorough understanding of ICH-GCP and FDA regulations.
  • Project management skills.
  • Great ability for planning and time management.
  • Excellent writing, presentation, and Communication skills.

 

Essential Skills

Clinical research managers require the following skills to succeed:

  • Interpersonal Skills:

A clinical research manager must possess strong interpersonal skills, including creating and maintaining productive working relationships with team members. As a clinical research manager, you must be able to work well with others to ensure that the goods your company sells to customers are secure. You must also establish productive working connections with other departments if you want them to provide you with the necessary resources to complete your projects on schedule.

  • Communication skill:

This is a crucial skill for all clinical research managers. Communication skills can be used to explain study results to a client, present research data to a group of investors, or convey research material to a group of researchers. Additionally, you can communicate with research participants by sending them emails or letters detailing the study methods.

  • Leadership Skill:

Clinical research managers should be able to motivate and guide a team of individuals toward common goals. This is necessary because clinical research managers usually oversee teams of individuals with various professional backgrounds and experience levels. Individuals in this career path with strong leadership qualities can better maintain order, set clear expectations, and inspire their teams to work hard.

  • Project management:

Clinical research managers require good project management abilities because they simultaneously supervise multiple initiatives. These initiatives may involve several different research, each with a unique set of rules and goals. Clinical research managers employ project management abilities to ensure that all necessary tasks are accomplished on time and that all data is collected appropriately.

  • Data Analysis:

Clinical research managers evaluate research data and determine the accuracy of the findings using data analysis techniques. Data analysis is also used to spot patterns in the data and assess whether the research is on track to achieve its objectives. This ability is crucial for assessing a research project’s success and modifying future projects.

  • Critical Thinking:

As a clinical research manager, you need critical thinking approaches to make decisions on your studies’ methods, tactics, and results. When problems arise during an examination or if a problem impacts the study’s findings, you may apply critical thinking to find the best solution. You also critically study the data to judge its reliability and accuracy.

 

 

  • A thorough understanding of research design:

Even if a candidate has previous experience working on clinical trials, knowing how to do standard research is insufficient for the post of clinical research manager. The clinical research manager must also be knowledgeable about clinical trial design, experimental protocol development, data collection techniques, and trial data storage and analysis.

  • Strong moral judgment and safety competence:

Clinical trials demand a firm understanding of the safety and ethical concerns surrounding medical research. A thorough understanding of how to look after and safeguard trial participants is essential. The ability to ensure that patients who have signed up understand what is required of them and their rights is a skill to be honed by those on this career path.

  • Budgeting:

As a clinical research manager, planning how to spend resources, like money or time, efficiently is one of your core responsibilities. However, clinical research managers usually develop budgets for their projects and may also need to keep track of costs as they arise. Those with great budgeting abilities can ensure they use corporate resources wisely and stay within their allowed budgets.

  • Expertise in the production of pharmaceuticals:

Bringing medicine or medical equipment to market is difficult, and a clinical research manager should be aware of it. Understanding how the U.S. Food and Drug Administration functions, the purposes of the various stages of clinical trials, and how to follow all relevant rules are necessary for this.

  • Observation Skills:

Clinical research managers thoroughly analyze patients throughout screening and trials. If they are to succeed, they must have great observational skills to identify changes and track relevant data.

  • Teamwork:

Clinical research managers work closely with various people throughout their careers, including other managers, researchers, patients, and company executives. As a result of this, they must have strong interpersonal communication skills to build productive teams and complete projects on time.

  • Knowledge of the techniques required for clinical trials:

In addition to having a general awareness of how clinical trials function and what is required by regulatory bodies, the clinical research manager should also have a thorough understanding of the practical activities associated with the clinical study. To guarantee the quality, they must be informed of the duties of the research team members and oversee all processes.

  • Attention to detail:

Clinical research managers are in charge of analyzing study data and ensuring that all protocols are adhered to precisely. They must pay special attention to detail for this. This is due to the possibility that mistakes or procedure breaches could taint the results and lead to inaccurate conclusions about the effectiveness of a particular treatment.

They are more likely to identify issues with trial planning or execution early on and resolve them before they become problematic if they pay great attention to the details.

 

How to Become a Clinical Research Manager

If you want to become a clinical research manager, here are steps to take:

  • Step 1: Earn a bachelor’s degree in a science discipline:

To work as a clinical research manager, you must have a bachelor’s degree in a scientific field like biology, chemistry, or health sciences. Several academic institutions offer clinical research programs and instruct students in both scientific and clinical research methods.

If your institution does not offer this program, you can still major in a relevant topic and take elective classes to learn more about clinical research. You can also think about returning to school for a graduate degree to advance your job. Clinical research managers with master’s degrees often earn more than those with bachelor’s degrees.

  • Step 2: Finish the clinical research manager training program:

Your next step in developing professionally is to complete a program for clinical research managers. After taking these courses, you will acquire the skills needed to plan research, communicate with study participants, and work alongside medical experts.

The Clinical Research Professional (CRP) title offered by the Association of clinical research professionals (ACRP) is one of the highest professional qualifications available for clinical research practitioners. To become certified, you must complete a recognized bachelor’s or master’s degree program in a pertinent scientific subject. A minimum of two years of experience working as a clinical research manager or assistant is also required.

  • Step 3: Hone your skills by working in a medical or research setting:

Once your education is complete, you can begin applying for entry-level work as a clinical research expert. These jobs are fantastic opportunities to gain experience working closely with patients and gain knowledge of the clinical research process. Working in these environments offers the chance to develop relationships with professors and instructors who may be able to suggest prospects for upcoming employment.

  • Step 4: Pass the certification exam for the Association of Clinical Research Professionals (ACRP):

The ACRP provides a certification exam for individuals working in clinical research to demonstrate their knowledge. To be eligible to take the test, candidates must have at least two years of relevant experience, including a full year in a professional job in clinical research. After three years, the certification can be renewed by completing continuing education courses.

  • Step 5: Develop your communication and organizational abilities:

Since clinical research managers engage with patients, their families, and other medical professionals, communication skills are crucial. They also need to be extremely well organized to handle the logistics of clinical trials. For instance, they might need to organize participants’ individual schedules and ensure that all the required equipment and materials arrive on time.

 

  • Step 6: Follow any changes in the world of clinical research:

New laws and regulations are routinely put into effect, and the clinical research industry is a sector that is always evolving. Clinical research managers must continue to stay up to date with these advancements to continue providing their patients with the finest care possible.

For instance, the U.S. Food and Drug Administration (FDA) announced new guidelines for clinical trials in 2016 that included stricter patient eligibility requirements and more rigorous monitoring practices. It’s crucial to keep up with any revisions to ensure that you follow all applicable laws and uphold the greatest levels of professionalism. These modifications might affect how clinical research experts perform their duties.

  • Step 7: Maintain your certification by fulfilling the criteria for ongoing education:

The ACRP mandates that clinical research experts complete 20 hours of continuing education every two years. You can complete these hours by taking online courses, live lectures, or webinars. The topics presented in these certification programmes are created to keep clinical research managers updated with the most recent industry standards and practices.

 

Where to Work as a Clinical Research Manager

Clinical research managers can be found working at hospitals, university departments, pharmaceutical firms, Healthcare, and government research organizations, to name a few. Although most of them work full-time, others may put in more than 40 hours a week to meet deadlines or manage the work of assistants. Clinical research managers might have to travel to meet with clients or attend conferences. Their job could be done in a lab or an office setting. Clinical research managers may come in touch with dangerous substances while carrying out their responsibilities. Thus, they must take care to protect themselves.

 

Clinical Research Manager Salary Scale

Clinical Research Managers with under a year of experience make an average of $70,733 a year (including tips, bonuses, and overtime pay). Clinical research managers earn an average salary of $70,383 during their first four years of employment. In the middle of their career, experienced Clinical Research Managers earn an average salary of $76,653. A clinical research manager with 10 to 19 years of experience can expect to make an average income of $83,987. Clinical research managers in their late careers (20 years and older) make an average pay of $92,131.

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