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Assistant Director, Clinical Trials

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How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Summary

A hybrid remote work option is available.

Being part of something greater, of serving a larger mission of discovery and care ? that's the heart of what drives people to work at Michigan. In some way, great or small, every person here helps to advance this world-class institution. It's adding a purpose to your profession. Work at Michigan and become a victor for the greater good.

The Office of Research and Sponsored Projects (ORSP) safeguards and advances U-M's research enterprise by providing its partners with efficient pre-award and non-financial post-award services for the compliant administration of externally sponsored grants, contracts, and ancillary agreements. We aspire to be recognized across the globe as the leading provider of innovative, and high-value guidance on the conduct of sponsored research and other funded activities. Additional information about us is ORSP at ourwebsite (https://orsp.umich.edu/about-orsp) .

Our office is growing and looking for experienced individuals to manage a team of Contract Officers and Sr. Contract officers who negotiate and execute contracts related to clinical trials for the institution. The incumbent in this position oversees a team that reviews, negotiates, and accepts clinical trials contracts and related agreements for the University of Michigan while also maintaining a complex portfolio and set of constituency assignments. This position has the responsibility and signature authority to review and agree to contractual terms and conditions on behalf of the University as a project representative in the Office of Research and Sponsored Projects. The Assistant Director, Clinical Trials (1) serves as the unit/team supervisor for one or more sponsored research contracting business lines; (2) drafts, analyzes, negotiates and executes a broad range of complex clinical trials agreements and contracts using a combination of expert-level skill, experience and knowledge of University, sponsor, and federal regulations and policies; (3) delivers scheduled and ad hoc training for staff within ORSP as well as the larger Research Administration community on campus; and (4) serves as a subject matter expert and conduit to key stakeholders and collaborators for ORSP office staff.

Under management of the Director, Contracts this position is responsible for the following areas:

Supervision

Manages a team of Contract Officers and Sr. Contract Officers. Provides daily guidance and mentoring to staff on operational and policy issues, as well as routine activities.

Reviews and monitors the daily workflow of contracts and agreements and reassigns work as needed. Maintains awareness of individual workload and flow of contracts and agreements and other administrative activities.

Facilitates cross-team collaborations to understand important and frequent contracting issues and to ensure seamless handoffs between Sponsored Project Officers and Contract Officers in all ORPS teams.

Hires, promotes, evaluates and counsels staff with input from direct supervisor and ORSP Leadership.

Identifies issues in ORSP contract and agreement workflows, provides recommendations to ORSP leadership for resolution and/or works with the appropriate offices to address.

Participates in the development and implementation of new policies and revisions to existing policies.

Leads ongoing service excellence and continuous improvement initiatives

Advises ORSP leadership on emerging and pressing issues. Participates in resolution of issues.

Training and Development

Delivers scheduled and ad hoc training for staff within ORSP and externally. Trains incoming contracts and negotiations staff on the negotiation of agreements within specific business line. Regularly reviews and updates training materials in concert with developments in the field and direction and feedback from the Director.

Contracting and Negotiation

Exercises signature authority for negotiation and execution of sponsored research agreements on behalf of U-M. Manages the drafting, analysis, negotiation and execution of a broad range of complex international and domestic clinical trial agreements and contracts applying a combination of expert-level skill, professional experience and knowledge of University, sponsor, and international and federal regulations (Uniform Guidance, Federal Acquisition Regulations, AAHRPP guidelines, GDPR, etc.) and policies. Agreements will include, but are not limited to master/umbrella, clinical trial, and material transfer agreements with corporate, government, non-profit and other entities. Safeguards university interests and mission objectives with respect to indemnification, intellectual property, publication, export control, liability, effort reporting, and compliance issues. Ensures compliance and fiscal integrity of incoming awards through consultation with ORSP leaders and other university stakeholders.

Outreach and Collaboration

Serves as a subject matter expert and ORSP conduit to key stakeholders (e.g., Office of General Counsel, Risk Management, Conflict of Interest, Innovation and Technology, Corporate Engagement, Development and Export Control) and collaborators for ORSP office staff. Provides comprehensive and concise advice and analysis on issues related to sponsored research contracting. Engages in collaborative educational and outreach efforts across U-M's campuses, with research administration and contracting associations (SRAI, NCURA, NCMA, MAGI) with peer universities (i.e., Big 10, FDP, COGR, AAU, NACUO, and UIDP member institutions), industry sponsors/partners and government agencies to establish and promote sustainable best practices in contracting and negotiations.

Why Work at Michigan?

In addition to a career filled with purpose and opportunity, The University of Michigan offers acomprehensive benefits package (https://hr.umich.edu/) to help you stay well, protect yourself and your family and plan for a secure future. Benefits include:

Generous time off

Many choices for comprehensive health insurance

Long-term disability coverage

Flexible spending accounts for healthcare and dependent care expenses and parental leave options

Hybrid working arrangements, including a combination of on-campus and remote work

A retirement plan that provides two-for-one matching contributions with immediate vesting

Dental and vision insurance

Required Qualifications*

Bachelor's Doctorate degree from an accredited institution or equivalent combination of education and experience.

U.S. Citizenship or Lawful Permanent Resident Status: ORSP deals with export controlled information, the handling of which is regulated by the U.S. Federal Government and access to which is restricted to U.S. Citizens and Lawful Permanent Residents.

Five (5) or more years of directly related experience.

Progressively responsible experience in contracts, research or grants administration in a university or directly related business or organization.

Working knowledge of federal regulations and contract management as they relate to institutions of higher education, medical centers and private organizations.

Desired Qualifications*

Juris Doctorate degree from an accredited institution or equivalent combination of education and experience.

Previous management experience leading a high-functioning team

Familiarity with U-M policies and procedures related to research administration (including, but not limited to, accounting, purchasing, personnel, and regulatory compliance).

Certification in Research Administration (CRA)

Working knowledge of sponsor software systems (e.g. eRA Commons, Research.gov, Proposal Central, etc.)

Additional Information

The Office of Research and Sponsored Projects seeks to recruit and retain a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and to maintain the excellence of the University. We welcome applications from anyone who would bring additional dimensions to the University's research mission, including women, members of minority groups, protected veterans, and individuals with disabilities. The Office of Research and Sponsored Projects, like the University of Michigan as a whole, is committed to a policy of nondiscrimination and equal opportunity for all persons and will not discriminate against any individual because of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, height, weight, or veteran status.

Background Screening

The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act.

Application Deadline

Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

Job Detail

Job Opening ID

248206

Working Title

Assistant Director, Clinical Trials

Job Title

Sponsor Project Assoc Director

Work Location

Ann Arbor Campus

Ann Arbor, MI

Full/Part Time

Full-Time

Regular/Temporary

Regular

FLSA Status

Exempt

Organizational Group

Umor Sponsored Projs

Department

UMOR Off Rsrch&Spnsr Prjs-ORSP

Posting Begin/End Date

4/25/2024 - 5/23/2024

Salary

$117,628.00 - $147,035.00

Career Interest

Research

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