THN Program Manager

University of Washington•Campus, IL

51d•$120,000 - $156,000

About The Position

As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills, and dedication to build stronger minds and a healthier world. UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits, and natural beauty. The Thoracic, Head, and Neck (THN) Research Program has an outstanding opportunity for a full-time Program Manager. The Program Manager oversees the management and operations of the Thoracic, Head, and Neck (THN) Research Program in the University of Washington's Division of Hematology and Oncology. This role oversees the implementation of collaborative research projects involving faculty from both the University of Washington (UW) and Fred Hutchinson Cancer Center (FH) and assists faculty leadership by advancing initiatives in support of the THN strategic plan. The Program Manager supervises and partners closely with teams responsible for fiscal management, regulatory affairs, trial start-up, and research coordination. Through strategic oversight and collaborative leadership, the Program Manager ensures integrated, compliant, and efficient end-to-end clinical trial operations. In alignment with institutional standards, this position will lead the development, documentation, and refinement of research procedures to promote consistency, streamline operations, and ensure regulatory compliance. This position ensures that all research activities, grants, and contracts adhere to applicable regulatory requirements, while fostering strong relationships with internal and external stakeholders. The role also includes direct supervision of a diverse team of research and administrative staff, working in concert with faculty and program leadership to support the broader mission of the THN Research Program. The THN Research Program includes 11 faculty members located at the UW Medical Center, and the Fred Hutchinson Cancer Center. Over the past 15 years, members of the Program have led practice-changing clinical trials. In addition, members of the Program have made substantial contributions to many other areas of cancer treatment, including the use of targeted therapies, cellular therapy for cancer, and antibody-based treatments. Functional areas for this position include: Clinical trial research management and research project management including assisting in obtaining grants that support research focus areas, providing fiscal oversight for a budget of up to $9,000,000, developing and negotiating clinical trial budgets with industry sponsors, assisting with the functional and academic aspects of investigator-initiated research, assisting faculty with data analysis, and supervising the THN Research Program staff.

Requirements

Bachelor's degree in business, science or health-related field.
Six or more years of experience in clinical trial coordination, clinical trial management, scientific or health-related research, or program administration.
Demonstrated success in the management of complex programs, activities, or units.
Thorough knowledge of IACUC, IRB, HIPAA, and FDA regulatory requirements for the conduct of research.
Excellent oral and written communication skills, organizational skills, and attention to detail. Strong collaborative and leadership skills.
Proficiency with standard MS Office software, including Word, Excel, and Power Point.
Ability to prioritize competing demands to successfully meet deadlines and project milestones.
Ability to work independently and make decisions as necessary; ability to manage multiple priorities and to coordinate projects in a complex organization.
Must be highly organized, flexible, and resourceful.

Nice To Haves

Knowledge of UW or FHCC financial systems, clinical systems and operations.
Experience in clinical trial start up
Prior management of multiple complex clinical trial budgets.
Experience working with industry sponsors.
Experience working with clinical research budgets/working in a clinical research environment.
Experience working with multiple teams, on multiple projects, and toward multiple deadlines strongly desired.

Responsibilities

In collaboration with the THN faculty, develop and implement clinical trial initiatives in support of the Program strategic plan.
Rapidly respond to key funding opportunities that match specific project proposals or that will further programmatic goals.
Oversee day-to-day operations, including assignments, coordination and review of research support services and work products, coordinate and attend staff and THN program meetings. Set expectations, demonstrate and teach strong teamwork and customer service skill sets. Oversee regulatory, records, and space management issues for the THN Program. Assist in the negotiation of clinical trial budgets and agreements.
Assist in the development and oversee implementation of complex inter-institutional research protocols, both investigator- and industry-initiated, that involve faculty from UW and Fred Hutchinson Cancer Center.
Understand and advise THN faculty on research development, regulatory, compliance issues.
Serve as an expert divisional resource to inter-institutional faculty and staff regarding federal and institutional (UW and FHCC) compliance requirements as they relate to clinical trials. Act as a divisional resource regarding audits (FDA, sponsor, and Institutional Review Boards). Serve as divisional resource for FDA Investigational New Drug applications and communication.
Develop and maintain standardized research procedures that ensure Program compliance with FDA, State, and inter-institutional regulations.
Oversee regulatory, records, and space management issues for each clinical trial. Plan and coordinate the preparation of clinical trial agreements with sponsors.
Develop and maintain close relationships with both internal and external partners. Work with industry contacts to optimize protocol development and efficient implementation.
Develop and maintain research procedures for the Program with the goal of standardization, increased efficiency and ensuring compliance with Institutional guidelines.
Oversee the development in negotiations with sponsors for clinical trial research budgets.
Communicate budget guidelines and restrictions to research staff to ensure overall fiscal compliance. Oversee post-award management of study finances. Oversee that communication is improved.
Collaborate with Division Central Administration to identify and implement strategies to mitigate areas of financial risk.
Understand the total costs and effort associated with clinical research and rapidly develop and defend appropriate budgets to support the research program.
Supervise inter-institutional research, finance and administrative staff. Provide leadership and mentorship to research and program staff to develop a broad and relevant skillset and advise/implement educational opportunities for growth.
Supervise, coordinate and review the work of staff. Estimate personnel needs and schedule and assign work to meet completion dates for research, finance and administrative staff.
Provide mentoring and training for research, finance and administrative staff.