Clinical Contracts Specialist (Contractor)United States

CareDx; Brisbane (CA); À distance; USD 63 000 - 89 000; Plein temps

Avantages offerts par ce poste

Remote work (US only)

Résumé du poste

CareDx, Inc. is seeking a highly experienced Clinical Contracts Specialist (Contractor) to independently manage complex clinical trial agreements and budgets. The role requires negotiation with sites, institutions, and vendors, in collaboration with Clinical Operations, Finance, Legal, Compliance, and Study Teams.

Remote-based with a 40-hour work week. The contractor will drive start-up timelines, ensure budget accuracy, and provide SME-level guidance on site contracts and payments, ensuring

Qualifications

• Bachelor's degree in Life Sciences, Business, Legal Studies or related field.
• 5+ years of experience in clinical contracting, budgets, CTAs, and negotiations with Sponsor and Institutions.
• Strong understanding of clinical trial operations, budgeting, and payment workflows.
• Knowledge of GCP, ICH, and FDA standards; able to work independently.

Responsabilités

• Lead end-to-end contracting for CTAs, amendments, MSAs, vendor agreements and related documents for global studies.
• Negotiate complex terms including budgets, payment schedules and termination clauses.
• Ensure contracts align with approved budgets, timelines and operational assumptions.

Connaissances

Negotiation skills

Budgeting

Contract negotiations

GCP/ICH/FDA knowledge

Formation

Bachelor's degree in Life Sciences, Business, Legal Studies

Outils

Medidata

CTMS

Grants Manage

Description du poste

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 November 2026 - April 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.

Remote: US only roles