Senior Site Contracts Specialist (Sponsor Dedicated /Remote – U.S. Only) Clinical Trial Contracts experience required!
Syneos Health · United States · 2 wk ago
RemoteRemoteBusiness Development$56k–$96k/yrFull-time
Job Responsibilities
- Lead Clinical Trial Contract & Budget Negotiations That Accelerate Research
- 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.
- Coverage of electronic repositories for contract execution and maintenance of required documentation and metadata.
- 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 escalate issues when appropriate.
Required Qualifications
- 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
- 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.
Preferred Qualifications
- Advanced degree.
- Previous experience supporting a Sponsor-Dedicated/FSP model.
- Leadership or mentoring experience.
- Vendor management experience.
- Experience supporting process improvement initiatives within Site Start-Up or Site Contracts.