Chapel Hill, North Carolina
Iowa City, Iowa
La Jolla, California
Bronx, New York
Posted: 04-Jan-23
Location: Chapel Hill, North Carolina
Salary: Open
Internal Number: 247064
Vacancy ID: NF0006559
Position Summary/Description:
UNC Lineberger Comprehensive Cancer Center (LCCC) oversees and coordinates oncology clinical trial research for UNC School of Medicine and UNC Cancer Care. UNC Lineberger Clinical Research (CR) is responsible for organizing, managing, conducting, and supporting oncology clinical trials. The Director of Sponsor Operations serves as a key member of CR non-faculty leadership overseeing sponsor operations of LCCC-sponsored investigator-initiated trials (IITs). This includes oversight of the multicenter project management, in-house monitoring, and compliance (data and safety monitoring, protocol review committee, national cooperative group project management, and audit) teams. This position oversees the LCCC CR strategic planning deliverables related to multicenter site clinical trial activation and accrual. Furthermore, this position is responsible for leading continued re-evaluation efforts of what support/oversight LCCC CR will provide to each category of clinical research (e.g., basic science, treatment). This individual leads this evaluation by accessing the level of compliance with applicable regulations on LCCC sponsored trials and driving process improvement/corrective action to address noncompliance. This role is responsible for the integration of and communication with decentralized infrastructure to ensure LCCC oversight as a clinical trial sponsor. This individual will lead strategic initiatives in multicenter growth of highly complex trials, such as leading expansion of efforts to create multicenter chimeric antigen receptor (CAR) T-cell trials.
The Director will lead interactions with individuals within and external to UNC including, but not limited to, protocol review and monitoring system (PRMS) Chairs, Office of Industry Contracting (OIC), Office of Sponsored Research (OSR), University Council, Office of Clinical Trials (OCT) Auditing Program, clinical trial funding sources (e.g., pharmaceutical companies), multicenter sites, and non-centralized oncology research partners. This position is responsible for building key relationships with other comprehensive cancer centers to ensure exchange of PRMS best practices. This individual will be responsible for contributing to comprehensive cancer center support grant (CCSG) renewals in regards to the PRMS section.
This position collaborates with the Director, Clinical Trial Activation to create critical path analysis and develop PERT charts for project tracking by the Multicenter Project Managers for the activation of multicenter investigator-initiated trial (IIT) sites. It designs reports and dashboards for executive, disease-group, sponsor, and leadership monitoring of activation progress of individual trials, and combined analysis of entire multicenter IIT portfolio. The individual will be responsible for identifying key activities on the critical path for targeted process improvement and leading the process improvement initiatives. Analyze activation costs of opening multicenter IIT sites and adjust budgeting for activation tasks accordingly. This individual develops and maintains a process for the project management of protocol amendment activation across multicenter sites including process mapping the amendment activation process. This individual leads efforts to optimize accrual at multicenter sites and tracks accrual across sites, studies, and the multicenter portfolio. They analyze site metrics to inform site selection (site budget, site compliance, site activation timelines, and site historical enrollment abilities) and provide reports and data to leadership to inform future collaborations and develop networks of closely integrated sites.
This position leads training of LCCC investigators and staff on IIT sponsor operations and develops and maintains standard operating procedures (SOPs), work instructions, and templates for sponsor operations, sponsor responsibilities, multicenter operations, oversight of cooperative group studies, and PRMS infrastructure.
Education and Experience:
Prior experience with Microsoft Projects highly preferred. Project Management Professional (PMP) certification highly preferred. Lean Six Sigma preferred. Previous experience in oversight of Cancer Center Support Grant (CCSG) protocol review and monitoring system (PRMS) and/or multicenter trial oversight preferred. Prior experience with OnCore highly preferred.
Master's degree of public health (MPH), or science (MS), Master of Business Administration (MBA), advanced clinical health science degree or life science PhD preferred. 3+ years of prior supervisory experience preferred.
