[Remote] Clinical Contracts Specialist (Contractor)

Note: The job is a remote job and is open to candidates in USA. CareDx, Inc. is a precision medicine company serving transplant patients and caregivers. The Clinical Contracts Specialist manages clinical trial agreements and study budgets, including complex negotiations, execution, and oversight. The role partners with Clinical Operations, Finance, Legal, Compliance, and study teams to support timely study startup, compliance, and budget accuracy.

Responsibilities

• Supports Study Start-Up (SSU) strategy in close collaboration with the Study Start Up Team Lead and the Study Start Up Managers to ensure SSU timelines and deliverables are met according to site contracts and budgets
• Serve as a subject matter expert and primary escalation point for site contracts, and budgets
• Lead the end-to-end contracting process 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
• Interpret and apply country specific contracting requirements, regulatory considerations, and institutional policies
• Ensure contract language aligns with approved budgets, study timelines, and operational assumptions
• Collaborate closely with Clinical Operations, Finance, and Payments teams to ensure contracted budgets are accurately reflected in clinical trial financial systems
• Review and approve site budgets, payment terms, and amendments for consistency with executed contracts
• Track and oversee contract status and budget review
• Identify and mitigate financial risks related to invoicing requirements, and payment triggers
• Support reconciliation activities and resolve site payment disputes related to contractual terms
• Act as a partner and lead during study start-up to support rapid site activation
• Manage contract amendments driven by protocol changes, enrollment updates, or scope adjustments
• Ensure all contracts and amendments, work orders, and SOWs are fully executed, compliant, and audit ready throughout the study lifecycle
• Serve as a trusted advisor and escalation point for complex contracting and budget issues
• Provide guidance to Clinical Operations, Study Management, and Finance teams on contractual interpretation and risk
• Partner with Clinical Operations and Legal to resolve non-standard terms and ensure compliance with company policies
• Contribute to the development and refinement of contracting standards, templates, SOPs, and playbooks
• Identify opportunities to improve cycle times, negotiation efficiency, and quality
• Provide resolutions of complex contract and budget issues, including escalations
• Participate in audits, inspections, and internal process reviews

Skills

• Bachelor's degree in Life Sciences, Business, Legal Studies, or a related field
• 5+ years of experience in clinical contracting, clinical budgets, clinical trial agreements, and negotiations with both Sponsor and Institutions
• Demonstrated experience negotiating complex CTAs and budgets within FMV parameters
• Strong understanding and deep expertise of clinical trial operations, budgeting, and payment workflows
• Ability to work independently and manage multiple high priority studies simultaneously
• Knowledge of GCP, ICH, and FDA standards
• Excellent written, verbal, and negotiation skills
• Supports diagnostic clinical trials including interventional trials and randomized, controlled trials
• Experienced with clinical trial financial systems (e.g., Medidata, CTMS, Grants Manage
• Leads complex, high-impact contracts independently
• Applies strategic, risk-based judgment with strong compliance focus
• Performs effectively with minimal to no training

Benefits

• For US employees: incentive compensation
• For US employees: health and welfare benefits, including a gym reimbursement program
• For US employees: 401(k) savings plan match
• For US employees: Employee Stock Purchase Plan
• For US employees: pre-tax commuter benefits
• Up to 30 days of paid leave annually for a full-time employee who donates an organ or bone marrow
• Remote-based; US only roles

Company Overview