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Clinical Trials Agreement Manager
2 months ago
Title:
Clinical Trials Contract Manager
Location:
Pittsburgh, PA (hybrid onsite, 2 days remote)
Type:
Full Time, Salaried with Benefits
Overview:
A highly esteemed Research University is in search of a Clinical Trials Contract Manager to enhance their Office of Clinical Trials.
In this role, you will oversee the comprehensive management of contract negotiations with sponsors and stakeholders, ensuring compliance with legal, regulatory, and institutional standards.
Responsibilities:
Contract Negotiation:
Direct negotiations with sponsors and other stakeholders to establish contract terms, budgets, and timelines.
Foster and sustain robust relationships with sponsors, ensuring clear communication and mutual understanding.
Regulatory and Legal Compliance:
Ensure that all contracts comply with local, state, and federal regulations, as well as institutional policies.
Remain updated on legal and regulatory changes that may impact clinical trial contract terms and conditions.
Documentation and Record Management:
Accurately document all phases of contract negotiations and finalized agreements in a systematic and retrievable manner.
Ensure accessibility and clarity of documentation for internal stakeholders and auditors.
Contract Modifications and Updates:
Oversee the amendment process for contracts as necessitated by changes in study protocols, budgets, or other unforeseen circumstances.
Ensure all modifications are properly documented and communicated to relevant parties.
Requirements:
A Law Degree is mandatory.
A minimum of 3 years of experience in clinical research contract management, demonstrating a successful negotiation record.
In-depth knowledge of regulatory guidelines and legal requirements relevant to clinical trial contracts.
Outstanding negotiation and communication abilities.
Proficient in contract management software and tools.
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