Caredxinc

Clinical Contracts Specialist (Contractor)

United States · Contract

Sponsorship not specifiedDetected 15 days ago

GCPNegotiationBudgetingClinical TrialsFDA RegulatoryBioinformaticsCollaboration

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.
CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.

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.
Lead the end-to-end contracting process for clinical trial agreements (CTAs), amendments, MSAs, vendor agreements and related documents for global studies.
Collaborate closely with Clinical Operations, Finance, and Payments teams to ensure contracted budgets are accurately reflected in clinical trial financial systems.
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.
Partner with Clinical Operations and Legal to resolve non-standard terms and ensure compliance with company policies.

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.
Strong understanding and deep expertise of clinical trial operations, budgeting, and payment workflows.
Knowledge of GCP, ICH, and FDA standards.
Required
Demonstrated experience negotiating complex CTAs and budgets within FMV parameters.
Ability to work independently and manage multiple high priority studies simultaneously.
Excellent written, verbal, and negotiation skills.
Preferred
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
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Clinical Contracts and Budgets Negotiations Financial Oversight
The successful candidate will demonstrate the experience and judgment required to immediately perform core responsibilities with minimal training.
Serve as a subject matter expert and primary escalation point for site contracts, and budgets.
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.
Review and approve site budgets, payment terms, and amendments for consistency with executed contracts.
Track and oversee contract status and budget review

5+ years of experience in clinical contracting, clinical budgets, clinical trial agreements, and negotiations with both Sponsor and Institutions

This listing is sourced directly from Caredxinc's careers page and normalized into a canonical job model.