Clinical Research Manager

The 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 Research 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; SOCRA / ACRP certification; 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.

Supervisory experience.

Experience in Phase I, II, and III clinical research.

Experience navigating medical records and data extraction.

Experience leading a large team. Special Physical / Mental Requirements Campus Security Authority Responsibilities