Title: Clinical Trials Contract Manager
Location: Pittsburgh, PA - On-site
Type: Full Time, Salaried with Benefits
Schedule: Monday-Friday Day
Overview:
Highly reputable Research University is seeking a Clinical Trials Contract Manager to join their team and play an integral role in the Office of Clinical Trials. You will be responsible for overseeing all aspects of contract negotiations with sponsors and stakeholders, ensuring legal, regulatory and institutional standards are met.
Responsibilities:
- Contract Negotiation:
- Lead negotiations with sponsors and other stakeholders to align on contract terms, budgets, and timelines.
- Build and maintain strong relationships with sponsors, ensuring transparent communication and mutual understanding.
- Regulatory and Legal Adherence:
- Guarantee that all contracts adhere to local, state, and federal regulations, as well as institutional policies.
- Stay informed of legal and regulatory changes that might affect clinical trial contract terms and conditions.
- Documentation and Record Keeping:
- Properly document all stages of contract negotiations and finalized agreements in a systematic and retrievable manner.
- Ensure easy access and clarity of documentation for internal stakeholders and auditors.
- Contract Amendments and 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 and communicated to relevant parties.
- Dispute Resolution:
- Serve as the primary point of contact for resolving any disputes or conflicts related to clinical trial contracts.
- Utilize negotiation skills and institutional resources to find amicable solutions while protecting the institution's interests.
- Quality and Integrity Assurance:
- Regularly review and refine the contract management process, ensuring its efficiency and effectiveness.
- Uphold the highest standards of quality and integrity in all contract-related activities to support the successful execution of clinical trials.
Requirements:
- 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 of experience in clinical research contract management, with a demonstrable record of successful negotiations.
- Thorough knowledge of regulatory guidelines and legal requirements pertinent to clinical trial contracts.
- Exceptional negotiation and communication skills.
- Proficient in contract management software and tools.
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