Clinical Operations Manager

UNC-Chapel Hill • Chapel Hill, NC

1d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Provides oversight and management of a large number of clinical research staff to ensure safe, compliant, efficient, and effective conduct of oncology clinical trials.
• Provides expert level knowledge in clinical trial practices and regulations.
• 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.
• Creates and champions a collaborative and positive relationship dynamic with internal staff and external agencies/organizations.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed