Clinical Contracts Specialist (Contractor)

CareDx, Inc.•Brisbane, CA
•Remote

About The Position

CareDx is seeking an experienced individual contributor to independently develop, negotiate, execute, and manage clinical trial agreements and study budgets with investigative sites, institutions, and vendors. The role manages complex, high-risk contracts and partners with Clinical Operations, Finance, Legal, Compliance, and Study Teams to support timely study startup, compliance, and budget accuracy. The contractor is expected to deliver results immediately with minimal to no training. The position is remote-based in the United States, scheduled for 40 hours per week, and listed as an assignment running from November 2026 to April 2026. The hourly rate is $55. The specialist supports study start-up strategy, leads end-to-end contracting for global studies, and serves as a subject matter expert and escalation point for contracts and budgets. They review contractual and budget terms for consistency, oversee contract status and budget reviews, address financial risks and payment disputes, and ensure agreements and amendments remain executed, compliant, and audit-ready throughout the study lifecycle. The role also contributes to process improvements, standards, templates, SOPs, and playbooks, and participates in audits, inspections, and internal reviews.

Requirements

  • Bachelor’s degree in Life Sciences, Business, Legal Studies, or a related field.
  • At least 5 years of experience in clinical contracting, clinical budgets, clinical trial agreements, and negotiations with both sponsors and institutions.
  • Demonstrated experience negotiating complex clinical trial agreements and budgets within fair market value parameters.
  • Strong understanding and deep expertise in 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.

Nice To Haves

  • Experience supporting diagnostic clinical trials, including interventional and randomized controlled trials.
  • Experience with clinical trial financial systems, such as Medidata, CTMS, or Grants Management.
  • Ability to lead complex, high-impact contracts independently.
  • Ability to apply strategic, risk-based judgment with a strong compliance focus.
  • Ability to perform effectively with minimal to no training.

Responsibilities

  • Support study start-up strategy with the Study Start Up Team Lead and Study Start Up Managers to meet timelines and deliverables tied to site contracts and budgets.
  • Serve as a subject matter expert and primary escalation point for site contracts and budgets.
  • Lead end-to-end contracting for clinical trial agreements, amendments, master services agreements, 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 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 contract status and oversee 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.
  • Partner with and lead study start-up activities to support rapid site activation.
  • Manage contract amendments arising from protocol changes, enrollment updates, or scope adjustments.
  • Ensure contracts, amendments, work orders, and statements of work are fully executed, compliant, and audit-ready throughout the study lifecycle.
  • Advise 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.
  • Resolve complex contract and budget issues, including escalations.
  • Participate in audits, inspections, and internal process reviews.

Benefits

  • Competitive base salary and incentive compensation
  • Health and welfare benefits
  • Gym reimbursement program
  • 401(k) savings plan match
  • Employee Stock Purchase Plan
  • Pre-tax commuter benefits
  • Up to 30 days of paid leave annually under the Living Donor Employee Recovery Policy for a full-time employee donating an organ or bone marrow
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