Senior Site Contracts Specialist – Clinical Trial Contracts

Role Overview

• Independently negotiating and managing Clinical Trial Agreements (CTAs), CTA amendments, and site budgets for U.S. and Canadian clinical research sites
• Drafting, cloning, reviewing, and negotiating site-specific CTAs from approved country templates
• Leading contract and budget negotiations directly with investigative sites while partnering with Sponsor stakeholders until all issues are resolved
• Applying approved CTA fallback language and budget negotiation parameters with minimal supervision
• Maintaining accurate contract negotiation status and milestones within the Sponsor's clinical trial tracking system
• Preparing amendments, revised budgets, and supporting documentation throughout the study lifecycle
• Performing quality control reviews to ensure contracts are complete, accurate, compliant, and execution-ready
• Coordinating contract execution and maintaining all required documentation and metadata within electronic repositories
• Partnering closely with Clinical Operations, Site Start-Up, Finance, Legal, and Site Contract Service Center teams to ensure efficient study activation
• Identifying contractual or operational risks early and proactively driving solutions
• Tracking contracting timelines, deliverables, and project milestones to support study start-up goals
• Serving as a trusted point of contact for internal teams, investigative sites, and Sponsor stakeholders
• Supporting customer meetings, business initiatives, and continuous process improvements
• Mentoring junior team members and contributing to SOPs, training materials, and quality initiatives
• Monitoring contract-related project metrics and escalating 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

Tech Stack

• Google Cloud Platform

Benefits

• Health benefits to include Medical, Dental and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time