Vacancy ID: NF0006558

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 primarily responsible for organizing, managing, conducting, and supporting these trials. The Director of Clinical Trial Activation serves as a key member of CR non-faculty leadership overseeing clinical trial activation of both new studies and of amendments to current studies and supervises and develops the staff who support these efforts. This position oversees of the LCCC CR strategic planning deliverables related to improvement of clinical trial activation timelines. This position oversees the Clinical Trial Activation Project Managers who perform project planning, execution, and tracking to ensure clinical trials are activated according to pre-set goals as defined by critical path analysis. This position leads critical path analysis for activation by clinical trial type (e.g., translational and correlative) and by sponsor type (e.g., pharmaceutical, CTEP (NCI CIRB) and investigator-initiated trials with and without an IND) and LCCC sponsor activities. This individual leads development of PERT charts for project tracking by the Clinical Trial Activation Project Managers. It designs reports and dashboards for executive, disease-group, sponsor and leadership monitoring of activation of individual trials, combined analysis of types of trials and combined analysis of entire portfolio. The individual will be responsible for identifying key activities on the critical path for targeted process improvement and leading the process improvement initiatives. The individual analyzes activation costs and adjusts budgeting for activation tasks accordingly. This position will lead key interactions/partnerships with external stakeholders to ensure timely activation. The position will also develop content to solicit new strategic partnerships with pharmaceutical companies in collaboration with the Director, Clinical Development.

This position will develop and maintain a process for tracking progress of protocol amendment activation and identify key activities requiring process improvement. This individual will lead the process improvement initiatives across functional groups to enhance the amendment activation process.

As part of overseeing activation, the Director oversees the pre-award finance team. The CR pre-award finance infrastructure is based on two main pillars: 1. Budgeting for initial clinical trials and amendments, and 2. Ensuring clinical trial systems including OnCore and Epic are set up to ensure proper patient and sponsor billing. This position leads standardization of budgeting processes and integration of external LCCC units into CR centralized financial support. This position collaborates with post-award finance to ensure expenses are covered and budgets are adjusted appropriately over time. This position leads process improvement initiatives to streamline development and execution of OnCore calendars and Epic billing calendars in conjunction with OnCore Enterprise and the Office of Clinical Trials.

This position leads training of LCCC investigators and staff in project management, activation and financial acumen and develops standard operating procedures (SOPs), work instructions, and templates for these processes. This position will be tasked with co-authoring manuscripts, abstracts and posters on clinical trial activation and project management best practices.

Education and Experience:

Prior experience with Microsoft Projects highly preferred. Project Management Professional (PMP) certification highly preferred. Lean Six Sigma preferred. Previous experience in clinical trial activation of oncology trials highly preferred. Prior experience with OnCore highly preferred, particularly in reference to use of task lists and the OnCore's financials console.

Master's degree in business administration (MBA) preferred. 3+ years of prior supervisory experience preferred.

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About The University of North Carolina at Chapel Hill

Carolina rates among the nation’s great institutions of higher education, set on an historic and beautiful campus that celebrates all four seasons. Carolina’s students, faculty and staff come here from around the world, bringing varied cultural, racial and ethnic heritages that help make UNC-Chapel Hill a thriving intellectual center. We’re repeatedly ranked the nation’s best value in higher education for students seeking to earn a college degree – the University has garnered the top spot each time since the ranking’s launch in 1998.Whether you’ve just started your career, are new to academia or are a seasoned professional with assorted campus experiences to draw on, we hope you will find a great place at Carolina.

Connections working at The University of North Carolina at Chapel Hill

https://careers.ispe-casa.org/jobs/17996457/director-clinical-trial-activation