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.

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.

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.

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.