Clinical Research Contract Manager at University of Pittsburgh in Pittsburgh, Pennsylvania

Job Description:

Clinical Research Contract Manager

Key Responsibilities:

Contract Negotiation: Lead negotiations with sponsors & other stakeholders to align on contract terms, budgets, & timelines. Build and maintain strong relationships with sponsors, ensuring transparent communication & mutual understanding.

Regulatory & Legal Adherence: Guarantee all contracts adhere to local, state, & federal regulations, & institutional policies. Stay informed of legal & regulatory changes that might affect clinical trial contract terms & conditions.

Documentation & Record Keeping: Properly document all stages of contract negotiations & finalized agreements in a systematic & retrievable manner. Ensure easy access & clarity of documentation for internal stakeholders & auditors.

Dispute Resolution: Serve as the primary point of contact for resolving any disputes or conflicts related to clinical trial contracts. Utilize negotiation skills & institutional resources to find amicable solutions while protecting the institution's interests.

Quality & Integrity Assurance: Regularly review & refine the contract management process, ensuring its efficiency & effectiveness. Uphold the highest standards of quality & integrity in all contract-related activities to support the successful execution of clinical trials.

Contract Amendments & Updates: Manage the process of amending contracts as required by changes in study protocols, budgets, or other unforeseen factors. Ensure all amendments are properly documented & communicated to relevant parties.

Qualifications:

Bachelor's degree in law, business administration, or related field • Advanced degree or certification in contract management or clinical research is a plus • Minimum of 3 years' experience in clinical research contract management, with a demonstrable record of successful negotiations • Thorough knowledge of regulatory guidelines & legal requirements pertinent to clinical trial contracts • Exceptional negotiation & communication skills • Proficient in contract management software & tools.

Job Summary

Responsible for managing the research contracts process and program and overseeing all aspects of contract negotiations with sponsors and stakeholders. Manages short-term objectives and contributes to long-term planning to support program goals, objectives and operations. This individual ensures that contracts meet legal, regulatory, and institutional standards, ensuring a solid foundation for the successful execution of clinical trials. Executes and helps set priorities related to the execution of the program operations.

Essential Functions

The Clinical Research Contracts Manager plays an integral role in the Office of Clinical Trials, overseeing all aspects of contract negotiations with sponsors and stakeholders. This individual ensures that contracts meet legal, regulatory, and institutional standards, ensuring a solid foundation for the successful execution of clinical trials.

Physical Effort

Ability to sit or stand for prolonged periods of time.

Ability to lift up to 25 pounds occasionally.

The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.

The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.

Assignment Category: Full-time regular

Job Classification: Staff.Clinical Research Contract Manager

Job Family: Research

Job Sub Family: Clinical Research

Campus: Pittsburgh

Minimum Education Level Required: Bachelor's Degree

Minimum Years of Experience Required: 3

Will this position accept substitution in lieu of education or experience: Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.

Work Schedule: Monday - Friday, 8:30 a.m. - 5:00 p.m.

Work Arrangement: Monday - Friday, 8:30 a.m. - 5:00 p.m.

Hiring Range: TBD Based Upon Qualifications

Relocation_Offered: No

Visa Sponsorship Provided: No

Background Check: For position finalists, employment with the University will require successful completion of a background check

Child Protection Clearances: Not Applicable

Required Documents: Resume

Optional Documents: Cover Letter

PI239632038

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