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Clinical Contracts Specialist – Contractor
CareDx, Inc.. Strategically develop, negotiate, execute, and manage clinical trial agreements and study budgets with investigative sites, institutions, and vendors .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial agreements, budgeting, and negotiations, with a strong understanding of regulatory standards such as GCP, ICH, and FDA. Proven ability to manage multiple studies, ensuring compliance and efficiency in contract execution and financial management.
Highest-signal resume keywords
Clinical Trial Agreements (CTAs)Negotiation of Complex ContractsClinical Trial BudgetingKnowledge of GCP, ICH, and FDA StandardsExperience with Clinical Trial Financial Systems
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ContractingBudget ManagementContract NegotiationRegulatory ComplianceFinancial Risk MitigationContractual InterpretationStudy Start-Up StrategyAudit ReadinessAmendment ManagementCycle Time Improvement
Soft Skills
Excellent Written CommunicationStrong Verbal CommunicationNegotiation SkillsIndependent Work CapabilityCollaboration
Tools & Technologies
MedidataCTMSGrants Management
Industry Keywords
Clinical TrialsInvestigative SitesSponsor NegotiationsInterventional TrialsRandomized Controlled Trials
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Strategically develop, negotiate, execute, and manage clinical trial agreements and study budgets with investigative sites, institutions, and vendors
- Support Study Start-Up strategy and ensure timelines and deliverables are met according to site contracts and budgets
- Serve as subject matter expert and primary escalation point for site contracts and budgets
- Lead end-to-end contracting for CTAs, amendments, MSAs, vendor agreements, and related documents for global studies
- 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, Payments, Legal, Compliance, and Study Teams
- Review and approve site budgets, payment terms, and amendments
- Track contract status and budget reviews; identify and mitigate financial risks
- Support reconciliation activities and resolve site payment disputes
- Manage amendments driven by protocol changes, enrollment updates, or scope adjustments
- Ensure contracts, amendments, work orders, and SOWs are fully executed, compliant, and audit ready
- Provide guidance on contractual interpretation and risk
- Contribute to contracting standards, templates, SOPs, and playbooks
- Improve cycle times, negotiation efficiency, and quality
- Participate in audits, inspections, and internal process reviews
Requirements
What you’ll need- 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
- Experience supporting diagnostic clinical trials, including interventional trials and randomized, controlled trials
- Experience with clinical trial financial systems, such as Medidata, CTMS, and Grants Manage
Benefits
Comp & perks- 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
- Up to 30 days of paid leave annually under the Living Donor Employee Recovery Policy for eligible full-time employees