Clinical Contracts Specialist (Contractor)

CareDx; United States; Remote; USD 63,000 - 89,000; Full time

Benefits offered by this job

Health and welfare benefits

401(k) matching

Employee Stock Purchase Plan

Gym reimbursement

Pre-tax commuter benefits

Paid organ donation leave

Job summary

CareDx is seeking an experienced contracts professional to lead end-to-end contracting for global clinical trial agreements, amendments, and related documents. You will negotiate budgets, timelines, and non-standard provisions while supporting site activation and study startup.

The role requires deep knowledge of clinical operations, GCP/ICH/FDA standards, and the ability to manage multiple high-priority studies independently.

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 sponsors and institutions.
• Demonstrated experience negotiating complex clinical trial agreements and budgets within fair market value parameters.
• Deep understanding of clinical trial operations, budgeting, and payment workflows.
• Knowledge of Good Clinical Practice, ICH, and FDA standards.
• Ability to work independently, manage multiple high-priority studies, and perform with minimal to no training.
• Excellent written, verbal, and negotiation skills.
• Experience supporting diagnostic clinical trials, including interventional and randomized controlled trials (preferred).
• Experience with clinical trial financial systems such as Medidata, CTMS, or Grants Manager (preferred).
• Strategic, risk-based judgment and experience independently managing complex, high-impact contracts (preferred).

Responsibilities

• Lead end-to-end contracting for global clinical trial agreements, amendments, master service agreements, vendor agreements, work orders, and statements of work.
• Negotiate complex contract terms, including budgets, payment schedules, termination clauses, and non-standard provisions.
• Support study startup strategy and rapid site activation while meeting contracting timelines and deliverables.
• Serve as the subject matter expert and escalation point for site contracts, budgets, and complex contracting issues.
• Ensure contract language aligns with approved budgets, study timelines, operational assumptions, regulatory requirements, and institutional policies.
• Collaborate with Clinical Operations, Finance, Legal, Compliance, Payments, and Study teams to maintain accurate financial systems and compliant agreements.
• Review and approve site budgets, payment terms, amendments, and budget changes for consistency with executed contracts.
• Track contract status and budget reviews, identify financial risks, reconcile payments, and resolve site payment disputes.
• Manage amendments resulting from protocol changes, enrollment updates, or scope adjustments throughout the study lifecycle.
• Develop contracting standards, templates, SOPs, and playbooks; support audits, inspections, and process improvements.

Skills

Negotiation

Communication

Independent worker

Education

Bachelor’s degree in Life Sciences/Business/Legal Studies

Tools

Medidata

CTMS

Grants Manager

Job description

Description:

• Lead end-to-end contracting for global clinical trial agreements, amendments, master service agreements, vendor agreements, work orders, and statements of work.
• Negotiate complex contract terms, including budgets, payment schedules, termination clauses, and non-standard provisions.
• Support study startup strategy and rapid site activation while meeting contracting timelines and deliverables.
• Serve as the subject matter expert and escalation point for site contracts, budgets, and complex contracting issues.
• Ensure contract language aligns with approved budgets, study timelines, operational assumptions, regulatory requirements, and institutional policies.
• Collaborate with Clinical Operations, Finance, Legal, Compliance, Payments, and Study teams to maintain accurate financial systems and compliant agreements.
• Review and approve site budgets, payment terms, amendments, and budget changes for consistency with executed contracts.
• Track contract status and budget reviews, identify financial risks, reconcile payments, and resolve site payment disputes.
• Manage amendments resulting from protocol changes, enrollment updates, or scope adjustments throughout the study lifecycle.
• Develop contracting standards, templates, SOPs, and playbooks; support audits, inspections, and process improvements.

Requirements:

• 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 sponsors and institutions.
• Demonstrated experience negotiating complex clinical trial agreements and budgets within fair market value parameters.
• Deep understanding of clinical trial operations, budgeting, and payment workflows.
• Knowledge of Good Clinical Practice, ICH, and FDA standards.
• Ability to work independently, manage multiple high-priority studies, and perform with minimal to no training.
• Excellent written, verbal, and negotiation skills.
• Experience supporting diagnostic clinical trials, including interventional and randomized controlled trials (preferred).
• Experience with clinical trial financial systems such as Medidata, CTMS, or Grants Manager (preferred).
• Strategic, risk-based judgment and experience independently managing complex, high-impact contracts (preferred).

Benefits:

• Contract position scheduled for 40 hours per week.
• Remote-based, US-only role.
• Hourly rate of $55.
• Health and welfare benefits, including gym reimbursement.
• 401(k) savings plan match.
• Employee Stock Purchase Plan.
• Pre-tax commuter benefits.
• Eligible full-time employees may receive up to 30 days of paid annual leave for living organ or bone marrow donation.