clinical research study manager

Clinical Research Manager Job Description [Updated for 2024]

In the era of innovative healthcare solutions, the role of clinical research managers has become increasingly significant.

As medical advancements continue to evolve, the demand for skilled professionals who can manage, streamline, and uphold the integrity of clinical trials grows stronger.

But let’s delve deeper: What’s truly expected from a clinical research manager?

Whether you are:

• A job seeker trying to understand the core of this role,
• A hiring manager defining the perfect candidate,
• Or simply intrigued by the intricate world of clinical research management,

You’re in the right place.

Today, we present a customizable clinical research manager job description template, designed for effortless posting on job boards or career websites.

Let’s dive right in.

Clinical Research Manager Duties and Responsibilities

Clinical Research Managers are responsible for overseeing and administering the operations and activities of clinical trials, including the recruitment of trial participants, management of research budgets, and ensuring compliance with protocols and regulations.

Their duties and responsibilities include:

• Developing and implementing protocols for clinical trials
• Planning and overseeing the clinical trial, from patient recruitment to data collection
• Ensuring that the clinical trials are conducted in accordance with ethical principles and within regulatory requirements
• Managing the clinical trial budget and resources, including negotiating contracts and managing payments
• Supervising the collection, storage and processing of data to maintain integrity and accuracy
• Monitoring and evaluating the progress of clinical trials and making necessary adjustments to ensure successful completion
• Preparing and presenting study findings to stakeholders and at scientific meetings
• Collaborating with investigators and other clinical staff to ensure the quality of research
• Training and mentoring clinical research coordinators and other team members
• Developing and maintaining relationships with sponsors, regulatory authorities, and other key stakeholders

Clinical Research Manager Job Description Template

We are seeking a detail-oriented and experienced Clinical Research Manager to oversee the daily operations of clinical trials.

In this role, you will be responsible for coordinating and supervising the activities of the clinical research team, ensuring compliance with protocols, and overall clinical objectives.

The ideal candidate will have a strong background in clinical research and a deep understanding of research methodology, regulations, and procedures.

They will also possess excellent leadership and project management skills.

Responsibilities

• Coordinate and oversee clinical studies from initiation to closeout
• Develop and implement policies, standards, and procedures for the clinical and data management aspects of projects
• Ensure all clinical studies are conducted in accordance with regulatory requirements and study protocols
• Manage resources, timelines, and quality of clinical projects
• Collaborate with internal teams and external partners to ensure the smooth running of clinical trials
• Oversee data management and analysis, and ensure data integrity
• Prepare and present reports on the progress and outcomes of clinical studies
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to applicable regulatory standards

Qualifications

• Proven work experience as a Clinical Research Manager
• Deep knowledge of Good Clinical Practice (GCP) guidelines, FDA regulations, and other applicable regulatory requirements
• Experience in clinical trials and knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
• Familiarity with clinical data management systems and procedures
• Strong leadership, project management, and team coordination skills
• Excellent analytical, decision-making, and problem-solving skills
• Advanced degree in a relevant field, such as Life Sciences, Medicine, or Healthcare Management
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

Additional Information

• Job Title: Clinical Research Manager
• Work Environment: This role is primarily office-based with occasional travel to clinical trial sites.
• Reporting Structure: Reports to the Director of Clinical Research.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $90,000 minimum to $150,000 maximum
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
• Application Instructions: Please submit your resume and a cover letter outlining your qualifications and experience to [email address or application portal].

What Does a Clinical Research Manager Do?

Clinical Research Managers primarily work in the field of healthcare and pharmaceuticals.

Their role is crucial to the progress and development of clinical trials and research studies.

They are responsible for planning and directing the clinical research projects, ensuring they are conducted in line with protocols, standard operating procedures, good clinical practice as well as ethical and legal requirements.

A significant part of their job involves designing and implementing research studies, including preparing project budgets, recruiting and managing research staff, and overseeing the collection, analysis, and interpretation of data.

They are responsible for coordinating with investigators, sponsors, and regulatory bodies and ensuring the quality control of the studies.

Clinical Research Managers often report on the progress of the research study, interpret and present study results, and prepare and publish study findings.

They may also be involved in contributing to the development of research objectives and proposals, conducting literature reviews and preparing grant applications.

They ensure participant safety and that the studies are carried out ethically and efficiently.

They may also be responsible for training and mentoring junior staff in clinical research.

Clinical Research Manager Qualifications and Skills

A competent Clinical Research Manager should have the skills and qualifications that align with your job requirements, such as:

• Strong knowledge of clinical research processes and protocols, including study design, budgeting, and data collection
• Exceptional organizational skills to manage multiple studies concurrently, ensuring that each is compliant with applicable laws and regulations
• Detail-oriented with the ability to record, transcribe, and maintain clinical data with accuracy and precision
• Strong interpersonal and communication skills to establish productive relationships with research teams, sponsors, and regulatory bodies
• Experience with statistical analysis, interpreting data and presenting the results in a clear and concise manner
• Problem-solving skills to effectively deal with issues that may arise during the clinical trial process
• Leadership skills and the ability to manage and motivate a team of research associates and assistants
• A strong understanding of ethical and patient safety considerations in clinical research

Clinical Research Manager Experience Requirements

Clinical Research Managers typically possess a Bachelor’s degree in a relevant field such as Life Sciences, Nursing, or Pharmacy, with a Master’s degree being highly desirable.

They should have at least 5-7 years of experience in clinical research, ideally with a focus on managing clinical trials.

Entry-level candidates may have experience as Clinical Research Associates or Clinical Research Coordinators, where they gain foundational knowledge in study protocols, patient recruitment and compliance, data collection and regulatory standards.

Intermediate candidates, with 3 to 5 years of experience, often have solid exposure to various aspects of clinical research including study design and protocol development, regulatory and ethical compliance, data analysis and reporting, and budget and resource management.

They may have led or supervised a small team or a simple project.

Seasoned candidates, with more than 5 years of experience, should have proven expertise in planning, executing, and overseeing multiple clinical trials, and should be adept at managing resources and leading multidisciplinary teams.

They are expected to have advanced knowledge of Good Clinical Practice (GCP), FDA regulations, and other relevant regulatory standards.

They may have additional specialized experience in areas such as oncology, cardiology, or neurology depending on the focus of their organization.

To advance into a Clinical Research Manager position, candidates often need to demonstrate strong leadership skills, strategic thinking, and the ability to oversee complex projects and troubleshoot issues effectively.

They should be adept at liaising with investigators, ethical review boards, regulatory authorities, sponsors, and other stakeholders.

Continuing professional development through relevant courses, certifications, and training can also strengthen a candidate’s suitability for this role.

For instance, obtaining a Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA) certification can be a valuable addition to their profile.

Clinical Research Manager Education and Training Requirements

Clinical Research Managers typically require a bachelor’s degree in a scientific or health-related field such as biology, chemistry, nursing, or public health.

To gain a solid foundation in clinical research procedures, regulatory requirements, and data management, they may also pursue a master’s degree in Clinical Research or a related field.

Moreover, they must have a comprehensive understanding of clinical trials protocols, Good Clinical Practice (GCP), and other relevant regulatory guidelines.

Prior experience in clinical research, which could be gained through internships or entry-level positions, is often necessary for Clinical Research Manager roles.

Specialized training or certification, such as a Certified Clinical Research Professional (CCRP) designation, can be beneficial and may be required by some employers.

Continuing education to stay up-to-date with the latest developments in the field is also important for Clinical Research Managers.

This could involve attending seminars, workshops, or completing additional coursework.

Leadership skills, a keen eye for detail, and strong organizational abilities are also crucial for succeeding in this role.

Clinical Research Manager Salary Expectations

A Clinical Research Manager can expect to earn an average salary of $97,462 (USD) per year.

The actual salary may vary depending on factors such as the individual’s level of experience, the size and type of the employing organization, and the geographical location of the job.

Clinical Research Manager Job Description FAQs

What skills does a clinical research manager need.

Clinical Research Managers need strong leadership and organizational skills to manage research teams effectively.

They must have excellent communication skills to liaise with different stakeholders like doctors, patients, and pharmaceutical companies.

Attention to detail is crucial to ensure the accuracy and validity of research data.

They should also have analytical skills to interpret complex research data and problem-solving skills to resolve any issues that may arise during the research process.

Do Clinical Research Managers need a specific degree?

Yes, Clinical Research Managers typically need to have a bachelor’s degree in a life science or health-related field at minimum.

However, many employers prefer candidates with a master’s degree or PhD.

Some also prefer candidates with a degree or certification in Clinical Research.

What should you look for in a Clinical Research Manager’s resume?

A Clinical Research Manager’s resume should showcase their experience in managing clinical research studies, knowledge of Good Clinical Practice (GCP) guidelines, and any relevant certifications like Certified Clinical Research Professional (CCRP).

Their resume should also include their experience with data analysis, project management, and budgeting.

What qualities make a good Clinical Research Manager?

A good Clinical Research Manager is ethical and respects the rights and welfare of study participants.

They are detail-oriented to ensure the accuracy of data and compliance with protocols.

They also need to be excellent communicators to coordinate with team members and other stakeholders.

Good problem-solving skills are crucial for troubleshooting any issues that arise during research.

Is it difficult to hire Clinical Research Managers?

Hiring Clinical Research Managers can be challenging due to the specific skill sets and education required for the role.

Candidates should have extensive experience in clinical research, knowledge of regulatory guidelines, and a strong scientific background.

The competitive nature of the healthcare and pharmaceutical industries also makes it a challenge to attract and retain talented Clinical Research Managers.

And there you have it.

Today, we’ve shed some light on what it truly means to be a Clinical Research Manager .

It’s not just about managing trials.

It’s about shaping the future of healthcare, one research study at a time.

With our trusty Clinical Research Manager job description template and real-life examples, you’re all geared up to take the next step.

But why stop there?

Dig deeper with our job description generator . It’s your roadmap to crafting meticulous job listings or refining your resume to perfection.

Every research study is a step towards a healthier world.

Let’s create that future. Together.

How to Become a Clinical Research Manager (Complete Guide)

Are You Earning Enough? Discover the Jobs with Surprisingly Low Salaries!

Happy Working: The Most Satisfying Jobs to Aspire For

Economic Warriors: Recession-Proof Jobs for a Stable Future

The Bright Side of Work: Enjoyable Careers That Lift Spirits

The Editorial Team at InterviewGuy.com is composed of certified interview coaches, seasoned HR professionals, and industry insiders. With decades of collective expertise and access to an unparalleled database of interview questions, we are dedicated to empowering job seekers. Our content meets real-time industry demands, ensuring readers receive timely, accurate, and actionable advice. We value our readers' insights and encourage feedback, corrections, and questions to maintain the highest level of accuracy and relevance.

Similar Posts

Green Marketer Job Description [Updated for 2024]

Glass Engraver Job Description [Updated for 2024]

DevSecOps Engineer Job Description [Updated for 2024]

Scenic Designer Job Description [Updated for 2024]

AWS Security Specialist Job Description [Updated for 2024]

Energy Dispatch Operator Job Description [Updated for 2024]

Leave a reply cancel reply.

Your email address will not be published. Required fields are marked *

Save my name, email, and website in this browser for the next time I comment.

Begin your journey with us – join our Early Career Talent Program! Apply today for Early Career Talent Program (Opens in new window)

Saved Jobs (0)

Job Details

Search Jobs

Clinical Research Manager

The Department of Dermatology (Dermatology Operations) within Stanford University, is a dynamic and innovative Department dedicated to excellence in research, medical education, and clinical care. Our Department is driven by over 70 faculty members and a cadre of staff who are the pillar of strength in the Department’s ongoing efforts into the prevention and treatment of various dermatologic diseases, conditions & disorders.

We are seeking a Clinical Research Manager (CRM) who is passionate about clinical research and project management. The CRM will report to the Associate Director, Clinical Research Operations and work with a robust clinical research team, hand in hand with Principal Investigators, Clinical Research Managers, Program Managers, and Associates in support of dermatology patients. The Clinical Research Manager will provide leadership and oversight of studies conducted by several affinity groups within the Department. The Clinical Research Manager will manage clinical research operations, relationships with other affinity groups and staff, study quality management, personnel management and career skill development, regulatory compliance, and fiscal oversight. The CRM will also assist with building automated clinical research workflows and solutions within the Department. The successful applicant will have the ability to supervise multiple clinical research staff, collaborate with external vendors, and enjoy working in a dynamic work environment. Exceptional diplomacy, interpersonal and communication skills are essential, as is a high degree of integrity. Attention to detail and the ability to manage multiple responsibilities simultaneously are also critical attributes.

Our Department strives to find team members who are passionate about their work, are creative and want to deliver results. We place a high priority on equipping our team members to perform their job efficiently, helping them acquire new skills and grow within the organization. We encourage our team members to have a healthy balance between work commitments and life outside of work and provide support to achieve this balance. If you are looking to make a large impact through global-reaching clinical research in a rapidly growing academic research organization, we encourage you to apply!

Note the position will be based on the Stanford Redwood City (SRWC) campus and is hybrid (working on-site and working from home) subject to operational needs.

Dermatology Clinical Research is a growing team that’s dedicated to supporting translational medicine and contributing to Stanford Medicine’s mission. We invite you to join our team!

Duties include:

• Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators.
• Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.
• Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.
• Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.
• Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
• Lead or chair committees or task forces to address and resolve significant issues.
• Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
• Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
• Assist with analysis of data and preparation of manuscripts and scientific presentations.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

• Experience developing reports and dashboards.
• Experience with Smartsheet.
• Experience with Notion.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Excellent interpersonal skills.
• Proficiency in Microsoft Office and database applications.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.
• Demonstrated managerial experience.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS*:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

• Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
• May require extended or unusual work hours based on research requirements and business needs.

WORK STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu .

The expected pay range for this position is $120,411 to $143,265 per annum/hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website ( https://cardinalatwork.stanford.edu/benefits-rewards ) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

Share this job

Similar jobs.

• Research Life Science Research Professional Stanford, California
• Research Clinical Research Coordinator 2 Stanford, California
• Research Life Science Research Professional 1 Stanford, California

About the Location

Find out what it’s like to live and work in Stanford, California.

Find your Fit

Jobs For You

No Recently Viewed Jobs.

No Jobs Saved.

Join Our Talent Community

Be the first to hear about job openings, upcoming events, and news at Stanford School of Medicine.

Country Code +1 +1242 +1246 +1264 +1268 +1284 +1340 +1441 +1473 +1649 +1664 +1670 +1671 +1684 +1758 +1767 +1784 +1849 +1868 +1869 +1876 +1939 +20 +211 +212 +213 +216 +218 +220 +221 +222 +223 +224 +225 +226 +227 +228 +229 +230 +231 +232 +233 +234 +235 +236 +237 +238 +239 +240 +241 +242 +243 +244 +245 +248 +249 +250 +251 +252 +253 +254 +255 +256 +257 +258 +261 +262 +264 +265 +266 +267 +268 +269 +27 +290 +291 +297 +298 +299 +30 +31 +32 +33 +34 +345 +350 +351 +352 +353 +354 +355 +356 +357 +358 +359 +36 +370 +371 +372 +373 +374 +375 +376 +377 +378 +379 +380 +381 +382 +385 +386 +387 +389 +39 +40 +41 +420 +421 +423 +43 +44 +45 +46 +47 +48 +49 +500 +501 +502 +503 +504 +505 +506 +507 +508 +509 +51 +52 +53 +54 +55 +56 +57 +58 +590 +591 +593 +594 +595 +596 +597 +598 +599 +60 +61 +62 +63 +64 +65 +66 +670 +672 +673 +674 +675 +676 +677 +678 +679 +680 +681 +682 +683 +685 +686 +687 +688 +689 +690 +692 +7 +77 +81 +82 +84 +850 +852 +853 +855 +856 +86 +872 +880 +886 +90 +91 +92 +93 +94 +95 +960 +961 +962 +963 +964 +965 +966 +967 +968 +970 +971 +972 +973 +974 +975 +976 +977 +98 +992 +993 +994 +995 +996 +998 Phone Number

Email Address

Upload Resume Remove

Opt-in Promotion

By signing up, I acknowledge I have read the Stanford Medicine privacy notice , and I wish to receive email communications. I understand I can opt out from receiving email communications at any time.

Confirm Email

Already signed up? Update your profile here .