Uw Clinical Trial Institute Contract Manager

Job Summary:
The Clinical Trials Institute (CTI) is a joint endeavor between the University of Wisconsin School of Medicine and Public Health (SMPH) and UW Health created to accelerate the academic medical center to the forefront of clinical trial operations and discovery. SMPH is a major academic unit of the University of Wisconsin - Madison (UW), a preeminent center for discovery, learning and engagement. SMPH accounts for over one-third of the research portfolio of the university which exceeds $1.3b in annual sponsored program awards. The school is closely affiliated with the University of Wisconsin Hospitals and Clinics Authority (UWHCA), an academic health system with annual revenues in excess of $3b.

The SMPH Contracts team presently consists of a small team of lawyers housed within the SMPH Fiscal Affairs Division, which supports contracting for various SMPH activities including federal and non-federal sponsored research, corporate agreements, fee-for-service agreements, data use agreements, nondisclosure agreements, industry consulting agreements, purchasing agreements, and university-related entrepreneurial agreements. The individual in this position will help grow this team's involvement in the rapidly expanding clinical trials space. The UW Clinical Trials Institute Contract Manager reports to the SMPH Director of Contracts within the Fiscal Affairs Division, and will participate regularly in the Clinical Trials Strategic Leadership Team meetings and other CTI-specific activities. Additionally, they will coordinate closely with the Administrative Director of the FDA Regulated Research Oversight Program.

The UW CTI Contract Manager will be responsible for managing the CTI's clinical trial agreements from idea inception through agreement execution. Working closely with our clinical trial agreement partners at the UW Office of Research and Sponsored Programs (RSP), this position will help to ensure timely, accurate processing of all clinical trial related agreements. This individual will develop agreement templates for industry and investigator sponsored studies, negotiate clinical trial agreements, non-disclosure agreements, and data-related agreements, and work closely with SMPH stakeholders to ensure institutional contracting goals are met.

Duties also include:
- assisting the budget development team
- maintaining and further-developing expertise in clinical trial laws, rules, and regulations, and
- disseminating knowledge about clinical trial agreements and compliance among various SMPH and UWHCA stakeholders.

This position requires a commitment to building strong relationships with both internal and external stakeholders. The individual in this position will regularly communicate with those stakeholders to ensure complete understanding of risk and compliance issues. This position works with multiple units of the university and health system including the Office of Research and Sponsored Programs, the Office of Legal Affairs, the Office of Cybersecurity, and Purchasing Services. This individual may work with the SMPH Contracts team to develop technological solutions for contract processing and management, and may be involved in policy development.
Responsibilities: Manages research administration activities or personnel related to pre-award functions including budget preparation, proposal submission, agreement negotiation, and/or project setup. Develops and oversees implementation of operations and strategic planning to ensure compliance with regulatory requirements within a unit. May manage a programmatic unit and/or personnel.

• 10% Develops, implements, and evaluates pre-award research administration operational policies and procedures including financial, administrative, staffing, and compliance
• 10% Works with researchers and prepares budgets, proposal submissions, agreements, or other agreements for sponsor consideration
• 20% Serves as a key resource to leadership and staff in the unit as well as a liaison to partners and stakeholders
• 50% May review and negotiate agreements on behalf of the unit
• 5% Assists with process improvement and data monitoring related to SMPH contracting
• 5% Modifying and drafting contracts, agreements, and memorandums of understanding (MOUs)
  for unique circumstances

Institutional Statement on Diversity:
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.

For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion
Education:
Preferred
Terminal Degree
JD is desirable.
Qualifications:
Required:
- Experience interpreting, applying, and communicating complex policies, procedures, legislation, or administrative rules.
- Ability to identify complex problems and review related information to develop and evaluate options and implement solutions.
- Ability to communicate clearly and concisely both orally and in writing.
- Attention to detail.

Strongly preferred:
- Four or more years of experience drafting, negotiating, or interpreting contracts at a major educational or healthcare institution.
- Experience drafting and/or negotiating Clinical Trial Agreements (CTA's) from either the academic or industry side.
- Experience drafting, negotiating, or interpreting contracts as a lawyer with a JD degree.

Preferred:
- Four or more years of experience drafting, negotiating, or interpreting contracts.
- Juris Doctorate degree.
- Four or more years of experience working in Clinical Trials.
- Experience developing and/or implementing technological solutions to improve processes.
- Certified Clinical Research Professional (CCRP) certification.
- Experience interpreting and applying privacy regulations including HIPAA.

Desired Knowledge, Skills, and Abilities:
- Ability to develop and/or implement technological solutions to improve processes.
- Ability to work collaboratively with cross-functional teams and build positive working relationships with stakeholders.
- Knowledge of federal guidelines/regulations pertaining to clinical research.
- Ability to research complex regulations.
- Ability to negotiate positive outcomes on behalf of a client.
- Knowledge about clinical trial documentation such as budgets, CTA, Protocols, and NDAs.
- Familiarity with project management/workflow/business intelligence software.
Work Type:
Full Time: 100%

This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.
Appointment Type, Duration:
Ongoing/Renewable
Salary:
Minimum $91,000 ANNUAL (12 months)
Depending on Qualifications
The starting salary for the position is $91,000 but is negotiable based on experience and qualifications.

Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at (https://hr.wisc.edu/benefits/).
- SMPH Academic Staff Benefits flyer: (https://uwmadison.box.com/s/r50myohfvfd15bqltljn0g4laubuz7t0)
Additional Information:
University sponsorship is not available for this position, including transfers of sponsorship. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1-OPT STEM Extension participants. If you are selected for this position you must provide proof of work authorization and eligibility to work.

The department will not be able to support a request for a J-1 waiver. If you chose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your legal or waiver fees.
How to Apply:
To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience.

You will also be asked to provide contact information for three (3) references, including your current/most recent supervisor during the application process. References will not be contacted without prior notice.
Contact:
Aisha Liebenow
liebenow@wisc.edu
608-262-5743
Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.
Official Title:
Pre-Award SPGC Mgr(SC018)
Department(s):
A53-MEDICAL SCHOOL/ADMIN/FISCAL AFFAIRS
Employment Class:
Academic Staff-Renewable
Job Number:
295152-AS