Senior Site Contracts Specialist – Clinical Trial Contracts
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Job Description
Senior Site Contracts Specialist independently managing clinical trial contract negotiations. Supporting a leading biopharmaceutical company with U.S. and Canadian site budget negotiations.
Responsibilities:
- 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
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
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