Senior Site Contract Specialist, Contract Manager (Sponsor Dedicated)

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

📋 Description

• Take charge of managing U.S. site contract and budget negotiations for a dedicated sponsor team.

• Assess contract language and study budgets for accuracy and completeness.

• Ensure that all revisions are accurately incorporated and documented.

• Keep internal project trackers updated with precise and timely information.

• Utilize sponsor-approved fallback language to negotiate terms of site contracts.

• Negotiate study budgets within established parameters while adhering to escalation procedures.

• Participate in weekly internal and external meetings, providing updates on progress.

• Collaborate with stakeholders on contract execution and timelines for site activation.

• Foster and maintain strong relationships with both internal and external stakeholders.

• Identify risks related to contracts and operations and develop strategies for resolution.

• Prepare packages for contract and budget escalations.

• Draft and finalize documentation for study start-up, including templates and plans.

• Prepare for and lead Study Team Kick-Off Meetings.

• Organize and facilitate meetings for contract and budget preparation and overview.

• Finalize contract documentation following negotiations and escalation approvals.

• Get involved in pilot programs and additional assignments supporting sponsor initiatives and personal development.

⛳️ Requirements

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

• At least two (2) years of direct experience in site contract and budget negotiations for Sr. SCS/Contract Manager 3.

• A minimum of one (1) year of direct experience in site contract and budget negotiations for SCS-II/Contract Manager 2.

• Minimum of one (1) year of progressive experience managing site contract negotiations as a client-facing point of contact within an industry-sponsored clinical trial setting for Sr. SCS/Contract Manager 3.

• Proven experience in independently managing Clinical Trial Agreements (CTAs), amendments, site budget negotiations, and the contract lifecycle with minimal oversight.

• Strong grasp of CTA drafting and negotiation, contract templates and fallback language, budget development and negotiation tactics, and clinical trial start-up processes.

• Experience in maintaining negotiation status and documentation in sponsor clinical trial tracking systems.

• Comprehensive understanding of Phase II-IV clinical trials, ICH-GCP, and clinical development processes.

• Strong skills in project management, organization, and prioritization.

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

• Proficient in Microsoft Office Suite.

• Preferred: experience in supporting a Sponsor-Dedicated/FSP model.

• Preferred: leadership or mentoring experience.

• Preferred: experience in a Contract Research Organization (CRO).

• Preferred: experience in supporting process improvement initiatives within Site Start-Up or Site Contracts.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Peer recognition and total rewards program.

• An inclusive workplace culture.

• Company car or car allowance.

• Comprehensive medical, dental, and vision health benefits.

• Company-matched 401(k) plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick leave provisions.

• Reasonable accommodations provided when appropriate.