Senior Site Contracts Specialist – Clinical Trial Contracts

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Independently negotiating and overseeing Clinical Trial Agreements (CTAs), amendments, and site budgets for clinical research sites in the U.S. and Canada.

• Drafting, cloning, reviewing, and negotiating site-specific CTAs based on approved templates from each country.

• Leading negotiations for contracts and budgets directly with investigative sites while collaborating with Sponsor stakeholders to resolve all issues.

• Applying approved fallback language for CTAs and budget negotiation parameters with minimal oversight.

• Keeping accurate records of contract negotiation status and milestones in the Sponsor's clinical trial tracking system.

• Preparing amendments, revised budgets, and necessary documentation throughout the lifecycle of the study.

• Conducting quality control reviews to ensure contracts are complete, accurate, compliant, and ready for execution.

• Coordinating the execution of contracts and maintaining all required documentation and metadata in electronic repositories.

• Collaborating closely with Clinical Operations, Site Start-Up, Finance, Legal, and Site Contract Service Center teams to facilitate efficient study activation.

• Identifying contractual or operational risks early on and proactively driving toward solutions.

• Monitoring contracting timelines, deliverables, and project milestones to support study start-up objectives.

• Acting as a reliable point of contact for internal teams, investigative sites, and Sponsor stakeholders.

• Supporting customer meetings, business initiatives, and ongoing process improvements.

• Mentoring junior team members and contributing to the development of SOPs, training materials, and quality initiatives.

• Monitoring metrics related to contract projects and escalating issues as necessary.

⛳️ Requirements

• Bachelor's degree in Business, Public Health, Life Sciences, or a related field (or equivalent experience).

• 2–3+ years of direct experience in negotiating clinical trial site contracts and budgets within a CRO, pharmaceutical company, or Sponsor-focused environment.

• Proven experience managing independently:

• - 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 in 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, organizational, and prioritization skills.

• Exceptional negotiation, communication, and relationship-building skills.

• Proficiency in Microsoft Office Suite.

🏝️ Benefits

• Health benefits including Medical, Dental, and Vision.

• Company match on 401k contributions.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on both company and individual performance.

• Flexible paid time off (PTO) and sick leave.