Clinical Operations Manager

University of North Carolina at Chapel Hill; Chapel Hill (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Comprehensive benefits

Paid leave

Health insurance

Retirement plans

Job summary

University of North Carolina at Chapel Hill is seeking a Clinical Operations Manager to oversee a large clinical research staff ensuring safe, compliant conduct of oncology trials. You will manage resources, maintain data integrity, and support regulatory adherence under the Clinical Protocol Office.

The role requires advanced knowledge of ICH GCP, strong organizational and communication skills, and flexibility to work with internal staff and external agencies.

Qualifications

• Advanced knowledge of ICH GCP, Federal Regulations and Guidelines.
• Experience in interviewing/hiring and performance management.
• Ability to plan work, coordinate multiple projects and lead a team.

Responsibilities

• Oversee clinical research staff across disease teams to ensure safe, compliant oncology trials.
• Ensure data integrity and regulatory compliance in all study activities.
• Support strategic planning, resource allocation and SOP development.
• Coordinate reporting, trainings and cross‑department collaboration.

Skills

ICH GCP knowledge

Federal Regulations

Regulatory compliance

Data integrity

Team leadership

Interviewing & hiring

Project management

Strong communication

Technology proficiency

Documentation & SOPs

Education

Master’s degree in related field

Bachelor’s degree in related field + 2 years research/analysis

Equivalent combination of training and experience

Tools

Microsoft Office

Clinical trial management systems

Data extraction tools

Job description

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.

University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC -Chapel Hill offers full-time employees a comprehensive benefits package , paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

Primary Purpose of Organizational Unit

Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education and research.

Patient care: We promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.

Education: We prepare tomorrow`s healthcare professionals and biomedical researchers from all backgrounds by facilitating learning within innovative and integrated curricula and team-oriented interprofessional education to ensure a highly skilled workforce.

Research: We develop and support a rich array of outstanding health sciences research programs, centers and resources. We provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our university to support outstanding research. We foster programs in the areas of basic, translational, mechanistic and population research.

Position Summary

The Clinical Operations Manager provides oversight and management of a large number of clinical research staff to ensure safe, compliant, efficient, and effective conduct of oncology clinical trials. This position provides expert level knowledge in clinical trial practices and regulations. This position works under the direct supervision of the Assistant Director of Clinical Research Operations to ensure safe implementation of oncology clinical trials. The Clinical Operations Manager manages clinical research staff assigned to various disease teams within the Clinical Protocol Office ( CPO ) providing daily management/supervision, resource and effort allocation, overseeing research compliance and data integrity, and assisting in strategic planning and operational support. This position creates and champions a collaborative and positive relationship dynamic with internal staff and external agencies/organizations.

Minimum Education and Experience Requirements

Master’s degree in a discipline related to the field assigned; or Bachelor’s degree in a discipline related to the field assigned and two years of research/analysis, preferably with one year in a supervisory role; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Required Qualifications, Competencies, and Experience

Advanced knowledge of ICH GCP , Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols; clinical research experience; Experience in interviewing/hiring process and performance management; Possess strong decision-making skills and the ability to problem solve and troubleshoot issues; Strong organizational skills with the ability to manage large volumes of information; High level of accuracy and attention to detail; High level of comfort with technology; Strong computer skills; Ability to gather data and document procedures; Ability to plan work and coordinate multiple projects; Ability to contribute to preparation and delivery of reports, trainings and SOPs; Customer oriented and ability to work within, build and lead a team; Exceptional interpersonal skills and excellent verbal and written communication skills in daily interactions with the ability to interpret and apply UNC policies and federal, state, and local regulations; Ability to work on evenings, weekends and/or holidays occasionally required.

Preferred Qualifications, Competencies, and Experience

• Therapeutic clinical trial coordination experience involving drugs and/or devices, to include work in oncology;
• SOCRA / ACRP certification;
• Supervisory experience;
• Experience in Phase I, II, and III clinical research;
• Experience navigating medical records and data extraction;
• Experience leading a large team.

Office of Human Resources Contact Information

If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at [phone] or send an email to [e-mail]
Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.

Equal Opportunity Employer Statement

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.

Required Documents

• Curriculum Vitae / Resume
• Cover Letter

Optional Documents

• List of References

Supplemental Questions

Required fields are indicated with an asterisk (*).

• * Please select the response below that describes your level of education that best or mostly closely satisfies the education requirements for this position.
  • Bachelor’s degree in required discipline(s) listed or related field
  • Bachelor's degree in any field/discipline
  • Master's degree or Doctorate degree in required discipline(s) listed or related field
  • Master's degree or Doctorate degree in any field/discipline
  • None of the above
• * Do you have SOCRA/ACRP Certification?
  • yes
  • no
• * What diseases/indications do you have experience working with?

  (Open Ended Question)

• * What phases of trials do you have experience with?

  (Open Ended Question)

• * Do you have experience with drug trials?
  • yes
  • no