Senior Site Contracts Specialist – Clinical Trial Contracts

Responsibilities

• Independently negotiate and manage Clinical Trial Agreements (CTAs), CTA amendments, and site budgets for U.S. and Canadian clinical research sites.
• Draft, clone, review, and negotiate site‑specific CTAs from approved country templates.
• Lead contract and budget negotiations directly with investigative sites while partnering with sponsor stakeholders until all issues are resolved.
• Apply approved CTA fallback language and budget negotiation parameters with minimal supervision.
• Maintain accurate contract negotiation status and milestones within the sponsor’s clinical trial tracking system.
• Prepare amendments, revised budgets, and supporting documentation throughout the study lifecycle.
• Perform quality control reviews to ensure contracts are complete, accurate, compliant, and execution‑ready.
• Coordinate contract execution and maintain all required documentation and metadata within electronic repositories.
• Partner closely with Clinical Operations, Site Start‑Up, Finance, Legal, and Site Contract Service Center teams to ensure efficient study activation.
• Identify contractual or operational risks early and proactively drive solutions.
• Track contracting timelines, deliverables, and project milestones to support study start‑up goals.
• Serve as a trusted point of contact for internal teams, investigative sites, and sponsor stakeholders.
• Support customer meetings, business initiatives, and continuous process improvements.
• Mentor junior team members and contribute to SOPs, training materials, and quality initiatives.
• Monitor contract‑related project metrics and elevate issues when appropriate.

Requirements

• Bachelor’s degree in Business, Public Health, Life Sciences, or a related field (or equivalent experience).
• 2–3+ years of direct clinical trial site contract and budget negotiation experience within a CRO, pharmaceutical company, or sponsor‑dedicated environment.
• Demonstrated experience independently managing:
  • Clinical Trial Agreements (CTAs)
  • CTA Amendments
  • Site budget negotiations
  • Contract lifecycle management with minimal oversight
• Strong understanding of:
  • CTA drafting and negotiation
  • Contract templates and fallback language
  • Budget development and negotiation strategies
  • Clinical trial start‑up processes
• Experience maintaining negotiation status and documentation within sponsor clinical trial tracking systems.
• Excellent understanding of Phase II–IV clinical trials, ICH‑GCP, and clinical development processes.
• Strong project management, organization, and prioritization skills.
• Exceptional negotiation, communication, and relationship‑building abilities.
• Proficiency with Microsoft Office Suite.

Demonstrates expertise in negotiating and managing Clinical Trial Agreements (CTAs) and site budgets, with a strong understanding of clinical trial processes and compliance standards. Proven ability to collaborate with cross‑functional teams and mentor junior members while maintaining accurate documentation and project timelines.