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.
We are seeking a highly experienced individual capable of operating independently and delivering results immediately upon start with minimal to no training.
The Clinical Contracts Specialist (Contractor) is an individual contributor responsible for including but not limited to the strategic development, negotiation, execution, and management of clinical trial agreements and study budgets with investigative sites, institutions, and vendors. This role, independently manages complex and high risk contracts, and partners cross-functionally with Clinical Operations, Finance, Legal, Compliance, and Study Teams to ensure timely study startup, compliance, and budget accuracy.
- This is a contract position.
- It is scheduled for 40 hrs/week.
- The assignment runs from July 2026 - December 2026.
- Hourly Rate: $55/hour
- Remote-based
Key Responsibilities
- 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.
- 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.
Other Responsibilities
- 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.
Qualifications
Required
- 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.
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
- Applies strategic, risk-based judgment with strong compliance focus
- Performs effectively with minimal to no training
Additional Details:
Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.
Our competitive Total Rewards package for US Employees includes:
- Competitive base salary and incentive compensation
- Health and welfare benefits, including a gym reimbursement program
- 401(k) savings plan match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- And more!
- Please refer to our page to view detailed benefits at https://caredx.com/company/careers
In addition, we have a 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.
With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.
CareDx, Inc. is an Equal Opportunity Employer-vets/disabled, and participates in the E-Verify program.
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This is the anticipated base salary range in the United States. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc. 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.
Skills Required
- Bachelor's degree in Life Sciences, Business, Legal Studies, or related field
- 5+ years experience in clinical contracting, clinical budgets, CTAs, and negotiations with sponsors 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 and randomized controlled trials
- Experience with clinical trial financial systems (e.g., Medidata, CTMS, Grants Management)
- Proven ability to lead complex, high-impact contracts independently
- Applies strategic, risk-based judgment with strong compliance focus
- Performs effectively with minimal to no training
What We Do
CareDx: Transforming Transplant Patient Care Through Novel Surveillance Management Solutions CareDx, Inc. is dedicated to improving the lives of organ transplant patients through non-invasive diagnostics. By combining the latest advances in genomics and bioinformatics technology, with a commitment to generating high quality clinical evidence through trials and registries, CareDx is at the forefront of organ transplant surveillance and pre-transplant HLA typing solutions. NASDAQ:CDNA About AlloSure® AlloSure is the first and only non-invasive blood test that directly measures allograft injury and identifies the probability of active rejection to better manage kidney transplant patients. AlloSure is a clinical-grade, proprietary Next-Generation Sequencing (NGS) based test to detect donor-derived cell-free DNA (dd-cfDNA) in order to identify organ injury in kidney transplant recipients. AlloSure is analytically validated as a sensitive, specific, and precise measurement of dd-cfDNA. AlloSure detects active rejection (acute active ABMR, chronic active ABMR, or TCMR) with high accuracy, outperforms serum creatinine in kidney transplant recipients, and is highly sensitive in distinguishing ABMR from no ABMR. AlloSure is performed in the CareDx CLIA-certified laboratory. http://www.allosure.com/ About AlloMap® AlloMap Molecular Expression Testing is a non-invasive blood test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing in conjunction with standard clinical assessment. AlloMap testing measures the expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an AlloMap test score. AlloMap is performed in the CareDx CLIA-certified laboratory and has been commercially available in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in 2011. Use of AlloMap is also included in the International Society for Heart and Lung Transplantation (ISHLT) Practice Guidelines, published in August 2010, the worldwide standard for the care of heart transplant patients. http://www.allomap.com/
