Clinical Contracts Specialist (Contractor)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Clinical Contracts Specialist (Contractor): Strategic development, negotiation, execution, and management of clinical trial agreements and study budgets with investigative sites, institutions, and vendors with an accent on complex, high-risk contracting and budget accuracy. Focus on end-to-end CTA/amendment/M SA/vendor contracting, applying GCP/ICH/FDA requirements, and resolving financial risks and site payment disputes to support timely study start-up.
Company
delivers precision medicine solutions and genomics-based information for transplant patients across the pre- and post-transplant journey.
What you will do
- Lead end-to-end contracting for clinical trial agreements (CTAs), amendments, MSAs, vendor agreements, and related documents for global studies.
- Independently negotiate complex contractual terms, including budgets, payment schedules, and termination clauses.
- Serve as subject matter expert and primary escalation point for site contracts and budgets; ensure contract language matches approved budgets, timelines, and operational assumptions.
- Collaborate with Clinical Operations, Finance, and Payments to ensure contracted budgets are reflected in clinical trial financial systems; review and approve site budgets and amendments.
- Track contract status and oversee budget review; identify and mitigate financial risks tied to invoicing requirements and payment triggers, including reconciliation and dispute resolution.
- Support study start-up by driving rapid site activation, managing amendment changes from protocol/enrollment/scope updates, and ensuring audit-ready execution.
Requirements
- Location: Remote (US only)
- Bachelor’s degree in Life Sciences, Business, Legal Studies, or related field.
- 5+ years of experience in clinical contracting and clinical trial agreements/budgets, including negotiations with both Sponsors and Institutions.
- Demonstrated ability to negotiate complex CTAs and budgets within FMV parameters; strong expertise in clinical trial operations, budgeting, and payment workflows.
- Knowledge of GCP, ICH, and FDA standards.
- Ability to work independently and manage multiple high-priority studies simultaneously; excellent written, verbal, and negotiation skills.
Culture & Benefits
- Competitive Total Rewards package for US employees, including health and welfare benefits and a 401(k) savings plan match.
- Employee Stock Purchase Plan and pre-tax commuter benefits.
- Living Donor Employee Recovery Policy: up to 30 days of paid leave annually for eligible organ/bone marrow donation.
- Contract role scheduled for 40 hrs/week from July 2026 to December 2026.
Hiring process
- Interviews to assess contracting experience, negotiation judgment, and ability to operate independently with minimal training.
- Evaluation of knowledge of GCP/ICH/FDA standards and experience with clinical trial budgeting/payment workflows.
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