Clinical Operations Manager

UNC-Chapel Hill; North Carolina; On-site; USD 90,000 - 135,000; Full time

Job summary

UNC-Chapel Hill is seeking a Clinical Operations Manager to oversee a large clinical research staff and ensure safe, compliant, efficient conduct of oncology clinical trials.

This role reports to the Assistant Director of Clinical Research Operations, coordinating staff and resources across disease teams, ensuring data integrity, and maintaining regulatory compliance while fostering collaboration with internal teams and external agencies.

Qualifications

• Advanced knowledge of ICH GCP, federal regulations and guidelines.
• Ability to follow established regulations, procedures, and protocols.
• Clinical research experience.
• Supervisory experience preferred.

Responsibilities

• Oversee and manage oncology clinical research staff and trial operations.
• Ensure compliance with GCP, regulations, and trial protocols.
• Coordinate resource allocation and workflow across disease teams.
• Foster collaboration with internal staff and external agencies.

Skills

ICH GCP knowledge

Regulatory compliance

Clinical research experience

Supervisory experience

Education

Master’s degree in related field

Bachelor’s degree in related field + 2 years experience

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