Req #: 241966

Department: SCHOOL OF MEDICINE

Job Location Detail: 100% remote work available

Posting Date: 01/07/2025

Closing Info: Closes On 01/14/2025

Salary: $7,635 - $11,453 per month

Limited Recruitment: Open to UW Employees only

Shift: First Shift

Notes: As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230701_a11y.pdf)

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 School of Medicine has an outstanding opportunity for a Contracts Manager to join their team.

The University of Washington (UW) is proud to be one of the nation’s premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research, and community service. Our staff not only enjoy outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty.

UW Medicine works to improve the health of the public by advancing medical knowledge, providing outstanding primary and specialty medical care to people of the region, and preparing tomorrow’s physicians, scientists and other health professionals. Within the large UW Medicine health system, the School of Medicine (SOM) is a world leader in biomedical research, with the largest biomedical research program at a public university based on National Institutes of Health funding and ranking among the top research universities internationally.

The Clinical Trials Office (CTO) supports the clinical research mission of UW Medicine. The CTO is an operational unit within the SOM’s Office of Research and Graduate Education charged with providing multi-service support to clinical researchers bringing important new therapies to our patients in compliance with evolving regulatory requirements.

POSITION SUMMARY

The Clinical Trials Office, in partnership with the Office of Sponsored Programs (OSP), has an outstanding opportunity for a Contracts Manager (Manager). Reporting to the CTO Senior Director, the Manager oversees and manages the team that negotiates clinical trial agreements for clinical trials and research studies across all therapeutic areas.

The Manager is responsible for the work of the Contracts Analysts, monitoring performance, managing assignments and coordinating workflow. They will use data analysis to assess compliance and ensure that UW policies and State and Federal law are followed. The Manager will develop, review or revise policy as needed to maximize contract compliance and efficiency.

This position will also review contracts and negotiate contract terms. As a subject matter expert, they will act as a mentor to junior and senior staff and encourage growth of both the individual and the team.

POSITION DIMENSIONS AND IMPACT TO THE UNIVERSITY

Clinical Trials Office is a central clinical research operation with compliance responsibilities and services across the vast portfolio of clinical trials in UW Medicine. The CTO operation has direct impact on UW reputation with major global biotech and biopharma sponsors, the availability of funded clinical trial opportunities in UW pipeline, and UW patients' access to novel therapies. In addition, the CTO plays a key role in mitigating institutional financial and reputational risks by ensuring strict compliance with the CMS and the FDA regulations and guidelines. The Manager is a key position in maintaining secure, efficient, and fully compliant clinical trials program at UW Medicine.

DUTIES AND RESPONSIBILITIES Management (40%)

• Supervise a team of Contracts Analysts responsible for review and negotiation of clinical trial and clinical study agreements.

• Develop position descriptions, hire and onboard new staff, and evaluate performance.

• Manage the team’s daily workflows and assignments. Coordinate personnel assignments with their schedules assuring continuity of services and meeting of metrics targets.

• Monitor and evaluate team’s performance metrics and KPIs, report metrics to Leadership on a regular basis.

• Oversee compliance of negotiated agreements with University policies and State and Federal regulations.

• Identify inefficiencies and process gaps that affect CTO customers, recommend improvements, and timely inform research investigators and study teams.

• Develop standardized productivity training and management tools.

• Ensure productive collaboration of the Contracts team with the CTO Budget and Regulatory teams to maintain alignment between contractual terms, budgetary needs, and regulatory documents.

• Participate in Leadership meetings and applicable working groups.

• Ensure effective and transparent communication with principal investigators, their departments, and study teams.Contract Review and Negotiation (40%)

• Review and evaluate terms and conditions for individual agreements, including Clinical Trial and Clinical Study Agreements, as well as Confidentiality Disclosure Agreements.

• Negotiate acceptable terms that are consistent with Federal and State law, University policy, processes, and systems, as well as originating sponsor or funder requirements.

• Collaborate with Department representatives and/or faculty during negotiations.

• Maintain efficiency and transparency with study teams during contractual negotiations.

• Consult with OSP colleagues to ensure consistent handling of agreements and use of contract terms.

• Maintain current and accurate agreement files of record.Mentorship and Training (10%)

• Provide training and mentorship to CTO Contracts Team regarding policies and contract negotiation process.

• Provide mentorship and guidance to study teams, department administrators, and investigators regarding specific contractual terms and PI responsibilities.Regulatory and Government Policy (10%)

• Stay abreast of the changing regulatory landscape.

• Maintain awareness of changes in UW, UW Medicine and funder policies and practices.

• Evaluate and make recommendations for adjustments to policies and processes needed because of changes in regulations or overall funder policies and practices. MINIMUM REQUIREMENTS

• Bachelor’s degree in science (including social sciences), healthcare, research, business administration or related field.

• Minimum six years of experience in grant or contract or research administration, or equivalent combination of education and experience. Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. ADDITIONAL REQUIREMENTS

• Demonstrated team leadership skills. Ability to make positive contributions and work effectively and efficiently in a group environment.

• Demonstrated ability to effectively manage a heavy work portfolio with competing priorities.

• Strong analytical and problem-solving skills.

• Attention to detail.

• Understanding of roles and responsibilities at a large research academic center.

• A demonstrated ability to work closely, collaboratively, and credibly with others.

• Knowledge of and experience with clinical trial contract drafting, negotiation, and execution process.

• Working knowledge of standard contract terms, such as confidentiality, intellectual property rights, and data ownership.

• Strong interpersonal and customer service skills.

• A demonstrated capacity to work with and within a diverse community.

• Excellent Microsoft Office suite skills. DESIRED QUALIFICATIONS

• Juris Doctorate or Master’s Degree in business or healthcare administration or related field.

• Experience working in UW systems, specifically, SAGE, OnCore, and Zendesk.

• Working knowledge of sponsor types and differing sponsor requirements.

• Knowledge of Federal regulations concerning management of Federal assistance funding, including the Uniform Guidance.

• Knowledge of Federal acquisition processes and Federal Acquisition Regulations (FAR). Application Process: The application process may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are access ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.

University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.