Senior Site Contracts Specialist - US - Remote

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Requirements:

• Mastery in negotiating complex contract terms with clinical sites and vendors.
• In-depth understanding of international and local regulatory requirements for clinical trials (e.g., FDA, EMA, ICH-GCP).
• Ability to explain complex contract terms clearly and concisely.
• Leadership skills to guide and support junior contract specialists.
• Ability to collaborate effectively with cross-functional teams, including legal, finance, data protection, and clinical operations.
• Bachelor's Degree or equivalent in business administration, finance, law, science, or related field.
• Proficiency with MS Word, Excel, and Outlook.
• Knowledge of ICH and GCP Guidelines and local country legislation in the sphere of clinical trials.

Responsibilities:

• Act as a Subject Matter Expert (SME) on Clinical Trial Agreement processes at country and site level.
• Preparation, negotiation, and finalization of site contracts and budgets.
• Manage the Investigator Budget and serve as a key liaison for contract-related communications.
• Resolve negotiation issues and escalating risks, drive process improvements, contribute to SOP development, and keep templates updated.
• Liaise and collaborate with Worldwide stakeholders and external stakeholders, such as sites and investigators.
• Review and finalize Clinical Trial Agreements and associated documents for completeness and accuracy.