Site Contracts Specialist - Europe - Remote

📋 Description

• • Prepare and maintain country-specific clinical trial contract templates to ensure regulatory and operational compliance across Europe.
• • Draft, issue, and manage Site Agreements and related contractual documents for clinical research sites, ensuring alignment with study protocols and sponsor requirements.
• • Negotiate contract language and financial terms directly with clinical sites, investigators, and sponsors to achieve mutually acceptable, executable agreements.
• • Review and analyze study budgets and cost structures to support accurate contract negotiations and financial compliance.
• • Conduct thorough quality assurance reviews of all Site Agreements and associated documentation prior to execution to ensure accuracy, completeness, and legal integrity.
• • Collaborate cross-functionally with the Worldwide Legal Department, Data Privacy team, study teams, sponsors, and clinical sites to resolve contractual issues and align on terms.
• • Manage the execution process by distributing fully signed agreements to relevant stakeholders including sites, eTMF, payment teams, and sponsors, and ensure proper filing on internal SharePoint.
• • Negotiate and prepare amendments to existing Site Agreements, including adjustments to scope, budget, or timelines, and coordinate their execution.
• • Draft and issue termination letters or other contractual closure documents as required by study changes or site discontinuations.
• • Maintain and update a real-time tracking tool with accurate, daily updates on contract status, negotiation progress, and execution milestones for all assigned sites.
• • Ensure adherence to international and local regulatory frameworks including FDA, EMA, and ICH-GCP guidelines throughout the contracting lifecycle.
• • Apply strong analytical skills to interpret complex contract clauses, identify potential risks, and propose effective mitigation strategies.
• • Communicate clearly and professionally in English with exceptional written and verbal skills, and leverage proficiency in Spanish, French, Polish, or German to support site negotiations in local languages.
• • Utilize MS Word, Excel, and Outlook efficiently to manage documentation, track timelines, and coordinate communications across global teams.
• • Support the Site Contracts team in maintaining a high standard of operational excellence and compliance across all European clinical trial sites.