Senior Site Contracts Specialist – Clinical Trial Contracts

🔥 1 minute ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $56.4k - $95.9k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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