Site Contracts Specialist

• Prepare country contract templates
• Draft and send Site Agreements and site-related contracts to begin negotiations
• Provide planned execution timelines and negotiation status
• Send items for translation and receive or translate items when applicable
• Review study budgets and costs related to contract negotiation
• Negotiate contract language and budgets with assigned sites through finalization and execution
• Escalate site requests outside preapproved parameters to the Site Contracts Lead and Sponsor
• Escalate risks and non-responsive sites to the Site Contracts Lead or internal team
• Add appropriate information or appendices to Site Agreements when equipment is provided
• Create donation agreements when applicable
• Review Site Agreements and associated contracts for completeness and accuracy
• Finalize contracts and budgets with sites
• Perform quality checks before the signature process
• Provide contracts and budgets to the regulatory team for submissions when requested
• Liaise with Legal, Data Privacy, study teams, Sponsors, sites, investigators, and other stakeholders
• Facilitate contract signatures
• Distribute fully executed agreements to sites, eTMF, payment team, Sponsor, and internal SharePoint
• Negotiate Site Agreement amendments and budgets
• Create termination letters and related documents
• Maintain tracking tools with live, real-time, or regular updates
• Prioritize effectively and respond to urgent requests
• Perform other duties as assigned

• Bachelor’s degree or equivalent in business administration, finance, science, or a related field
• 1 to 3 years of experience in the Contract Research Organization, pharmaceutical, or clinical research industry, working with investigator/site contracts or a related legal field
• Excellent verbal and written English language skills
• Proficiency with Microsoft Word, Excel, and Outlook
• Knowledge and understanding of International Council for Harmonization (ICH) and Good Clinical Practice (GCP) guidelines
• Knowledge of local country legislation and regulatory requirements related to clinical trials
• Proficiency in negotiating contract terms with clinical sites and vendors
• Ability to identify and address contract issues and disputes efficiently
• Understanding of international and local regulatory requirements for clinical trials, including FDA, EMA, and ICH-GCP
• Strong analytical, communication, project management, problem-solving, time management, and organizational skills
• Proficiency in contract management software and tools
• Understanding of budgeting and financial principles related to clinical trial contracts
• Basic understanding of legal terminology and principles related to contracts
• Ability to work effectively with cross-functional teams, including legal, finance, and clinical operations
• Ability to handle high volumes of work and work under pressure

• Equal employment opportunities
• Diverse and inclusive work environment
• Supportive and collaborative teams
• Accessible leadership
• Employee opportunities to succeed and develop professionally