Easter Seals Jobs

Req #: 242426

Department: SCHOOL OF MEDICINE

Job Location Detail: Hybrid/Remote eligible

Posting Date: 01/10/2025

Closing Info: Closes On 01/17/2025

Salary: $7,548 - $11,322 per month

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 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 has an outstanding opportunity for a Manager, Trial Start-up and Special Projects (Manager). Reporting to the CTO Senior Director, the Manager oversees and manages the implementation of strategic initiatives to optimize clinical trial start-up and to consolidate clinical trial support for clinical departments and principal investigators across multiple therapeutic areas.

As subject matter expert, the Manager optimizes clinical trial start-up services, by enhancing and integrating start-up processes, including trial feasibility, study budget development and negotiation, regulatory submissions, and contracting. They mentor multi-team staff involved in various aspects of trial start-up operations, as well as develop and execute staffing plans for their own team. The Manager will be responsible for identifying opportunities to enhance services and support to deliver on UW Medicine strategic goals. The Manager must have strong leadership skills and be able to juggle multiple shifting priorities involving many different stakeholders.

This position is a part of the CTO Strategic Leadership and CTO Operations Leadership groups and reports to the CTO Senior Director.

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. CTO Manager of Start-up and Special Projects is a key position in maintaining efficient, cost effective, and compliant clinical trials program at UW Medicine.

DUTIES AND RESPONSIBILITIES Trial Start-up (70%):

• Assist senior leadership in defining strategic direction to enhance clinical trial start-up services, including, but not limited to, trial feasibility, budget development and negotiation, integration of regulatory, budgetary and contractual start-up.

• Develop and implement templates and master solutions to standardize start-up operations.

• Develop position descriptions, hire and onboard new staff, evaluate work performance, provide mentorship and training to junior and senior staff. Recommend promotions and staffing plans to CTO Leadership.

• Direct supervision of three start-up staff, with additional supervisory responsibility in the future.

• Monitor and evaluate start-up performance metrics and KPIs, report metrics to Leadership on a regular basis.

• Identify inefficiencies and process gaps that affect UW research teams and recommend improvements.

• Assess and recommend optimal staffing model for start-up operations and services.

• Develop standardized productivity training and management tools, making improvements when necessary.

• Oversee collaboration between the CTO Budgets, Contracts, and Regulatory teams to maintain alignment between contractual terms, budgetary needs, and regulatory documents. Ensure that this collaboration remains productive, efficient, and aligned with CTO and UW Medicine goals and KPI targets.

• Key contributor in leadership meetings and applicable working groups.

• Ensure effective and transparent communication with principal investigators, their departments and study teams.Special Projects (20%)

• As part of strategic assessment, identify opportunities to enhance services and support for physician investigators and their clinical research teams.

• Manage implementation of assigned new strategic initiatives and plan staffing model to support these services.

• Collaborate with departmental representatives and principal investigators during these special assignments to ensure support and buy-in for new initiatives.

• Maintain efficiency and transparency with study teams while working on these special assignments.Mentorship and Training (10%):

• Provide training and mentorship to CTO Budget and Regulatory teams regarding procedures, policies, and trial budget negotiation process.

• Provide mentorship and guidance to study teams, department administrators, and investigators regarding specific start-up workflows and PI responsibilities. MINIMUM REQUIREMENTS

• Bachelor’s degree in healthcare, science, business administration or related field.

• Minimum five years of experience in clinical research administration. Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. ADDITIONAL REQUIREMENTS

• Knowledge of and experience with clinical trial start-up process, including budget development and negotiation and/or regulatory start-up.

• 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.

• Strong interpersonal and customer service skills.

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

• Excellent Microsoft Office suite skills. DESIRED QUALIFICATIONS

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

• Experience managing clinical trial start-up teams and processes.

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

• Working knowledge of sponsor types and differing sponsor requirements. 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.