Clinical Contracts Specialist (Contractor)

About the role

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. We are seeking a highly experienced individual capable of operating independently and delivering results immediately upon start with minimal to no training.

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.
• 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.

Qualifications

• 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.

Additional Details

• Competitive Total Rewards package for US Employees includes:
• Health and welfare benefits, including a gym reimbursement program
• 401(k) savings plan match
• Employee Stock Purchase Plan
• Pre-tax commuter benefits
• Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.
• Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units.
• CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.
• Remote: US only roles
• $55 - $55 USD