Senior Contracts Analyst

Job Description

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 tomorrows 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 SoMs 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.

The Clinical Trials Office in partnership with the Office of Sponsored Programs (OSP) has an outstanding opportunity for a Senior Contracts Analyst (Senior Analyst). Reporting to the CTO Contracts Manager the Senior Analyst is responsible for drafting and negotiating the terms of clinical trial agreements for clinical trials and research studies across all therapeutic areas.

This position is responsible for drafting intricate and complex clinical trial agreements. These robust agreements cover a variety of complex contractual terms (intellectual property payment terms publication rights subject injury insurance terms indemnification amendments dispute resolution etc.). The Senior Analyst must maintain awareness of changes in regulatory policy government policy and University policy to ensure that contracts are drafted with awareness of up-to-date rules and regulations.

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 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 Senior Analyst is a key position in maintaining secure efficient and fully compliant clinical trials program at UW Medicine.

DUTIES AND RESPONSIBILITIES

Contract Review and Negotiation (90%)

• Review and evaluate terms and conditions for individual agreements including complex Clinical Trial and Clinical Study Agreements as well as Confidentiality Disclosure Agreements.
• Timely and expertly negotiate mutually acceptable terms with large pharmaceutical and biotechnology corporations as well as large academic medical centers site networks private pharma and tech companies foundations non-profit organizations using multiple negotiation strategies and techniques.
• Ensure that the negotiated terms are consistent with Federal and State law University policy processes and systems as well as originating sponsor or funder requirements.
• Collaborate with physician investigators and departmental administrators and other representatives during negotiations.
• Maintain target turnaround goals and transparency with study teams during contractual negotiations.
• Consult with OSP colleagues to ensure consistent handling of agreements and use of contracts terms.
• Maintain current and accurate agreement files of record.
• Other duties as assigned.

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

• Bachelors degree in science healthcare research business administration or related field
• Minimum four years of experience in grant and/or contract administration. Additional experience may be substituted for the degree requirement

Additional Requirements.

• 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 contract drafting negotiation and execution
• 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 all people.
• Excellent Microsoft Office suite skills

DESIRED QUALIFICATIONS

• Masters or Juris Doctorate degree preferred

• Understanding of clinical trial start-up process and life cycle
• 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)

Compensation Benefits and Position Details

Pay Range Minimum:

Pay Range Maximum:

Other Compensation:

Benefits:

Temporary or Regular

FTE (Full-Time Equivalent):

Union/Bargaining Unit:

About the UW

Working at the University of Washington provides a unique opportunity to change lives on our campuses in our state and around the world.

UW employees bring their boundless energy creative problem-solving skills and dedication to building stronger minds and a healthier return they enjoy outstanding benefits opportunities for professional growth and the chance to work in an environment known for its diversity intellectual excitement artistic pursuits and natural beauty.

Our Commitment

The University of Washington is committed to fostering an inclusive respectful and welcoming community for all. As an equal opportunity employer the University considers applicants for employment without regard to race color creed religion national origin citizenship sex pregnancy age marital status sexual orientation gender identity or expression genetic information disability or veteran status consistent with UW Executive Order No. 81.

To request disability accommodation in the application process contact the Disability Services Office at or .

Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.