What are the responsibilities and job description for the Clinical Trials Contract Manager position at System One Holdings, LLC?
Title : Clinical Trials Contract Manager
Location : Pittsburgh, PA
Type : Full Time, Permanent
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.
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 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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