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Senior Specialist, Site Contracts

About the role

• Act as a Subject Matter Expert on Clinical Trial Agreement processes at country and site level
• Prepare, negotiate, and finalize site contracts and budgets
• Manage the Investigator Budget and serve as a key liaison for contract-related communications
• Resolve negotiation issues and escalate risks
• Drive process improvements
• Contribute to SOP development and keep templates updated
• Liaise and collaborate with Worldwide stakeholders and external stakeholders, including sites and investigators
• Review and finalize Clinical Trial Agreements and associated documents, including site budgets, for completeness and accuracy
• Review, analyze, and draft clinical research site contracts, investigator contracts, and other project-related contracts
• Negotiate and finalize clinical trial contracts and services contracts with the Worldwide Legal Department, study teams, sponsors, investigators, and clinical sites

• Mastery in negotiating complex contract terms with clinical sites and vendors
• In-depth understanding of international and local regulatory requirements for clinical trials, including FDA, EMA, and 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 legal, finance, data protection, and clinical operations teams
• 3–4 years of experience as a Senior Site Contracts Specialist or minimum 5 years of Site Contract experience in the clinical research, pharmaceutical, or CRO industry
• Bachelor's Degree or equivalent in business administration, finance, law, science, or a related field
• Proficiency with MS Word, Excel, and Outlook
• Knowledge and understanding of ICH and GCP Guidelines, local country legislation in clinical trials, and local regulatory requirements
• Adept knowledge of the biopharmaceutical/CRO industry and applicable local regulatory requirements

• Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law
• Diverse and inclusive work environment
• Supportive teams and accessible leadership
• Professional opportunity to collaborate with global stakeholders