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Due to a growing portfolio, we are currently looking for an experienced Site Contract Specialist/ Senior Clinical Contracts Analysts. As Site Contract Associate you will be responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies.
Job Responsibility:
Negotiate and maintain Clinical Trials Agreements (CTA), site budgets, Confidential Disclosure Agreements, Consultant Agreements, and other applicable contracts
As required, oversee CRO or Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocols
Ensures compliance of contracts with Fair Market Value (FMV) principles and guidelines
Track contract progress, complete required follow-ups and coordinate the timely completion of clinical sites contracts
Oversee CRO and Functional Service Provider activities in regards to site CDAs
Collaborate and coordinate with cross-functional teams
R&D, Legal, Compliance, Procurement and Finance in executing contracts
Develop, maintain, and analyze tools and systems (spreadsheets, Smartsheet, databases, etc.) to manage contract lifecycle from initiation through contract execution, and build internal metadata to support accurate reporting
Provide guidance and direction to new clinical operations and/or outsourcing team members and R&D teams on site contracts & budgets processes
Requirements:
Bachelor's degree in a related field (e.g., law, economics, business, social sciences), equivalent training or industry experience
Proficient with Excel and PowerPoint
Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety
Ability to prioritize and manage multiple tasks simultaneously