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Clinical Trial Manager

CareDx· RESEARCH & DEVELOPMENT
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Brisbane, CA$124k - $155kPosted 4mo ago

About the role

Oversees and coordinates end-to-end execution of clinical trials for CareDx, ensuring on-time delivery, data quality, regulatory compliance, and cross-functional collaboration across Clinical Operations, Data Management, Medical Affairs, and external vendors.

Responsibilities

  • Lead the end-to-end execution of CareDx clinical trials, including site identification, study start-up, study conduct, monitoring and closeout, with accountability for timelines, budget, metrics, IRB/EC submissions, and study document development.
  • Drive site activation, enrollment, and overall study performance aligned with protocols and business objectives.
  • Identify study risks (timeline, quality, operational), lead mitigation planning and execution, and escalate issues with action plans and ownership.
  • Conduct internal review of investigator contracts and payments as necessary.
  • Provide cross-functional leadership to ensure clear roles, accountability, and seamless trial execution across Clinical Operations, Data Management, Medical Affairs and other functions.
  • Prepare and present project debriefings to Clinical Operations management and cross-functional teams.
  • Oversee Clinical Research Associates, CROs, central labs, and external vendors, ensuring high-quality, timely, cost-effective deliverables through governance and KPIs.
  • Champion operational excellence by standardizing study execution models, optimizing vendor management and reporting frameworks, and implementing scalable processes and SOPs.
  • Ensure data quality and inspection readiness via proactive data review and collaboration with monitoring and data management teams; identify and mitigate risks across timelines, quality, and operations.
  • Maintain strong communication with clinical sites and stakeholders, including site visits, study documentation, and reporting, ensuring GCP and regulatory compliance.
  • Support study administration activities such as site engagement, training, and product inventory management for efficient study execution.
  • Ensure high-quality, inspection-ready documentation and study tracking through effective eTMF management and real-time study status reporting.
  • Provide oversight and operational support for CTMS to track milestones, enrollment, monitoring activities, and performance metrics.
  • Directly lead and manage clinical operations personnel.

Qualifications

  • Bachelor’s degree in life sciences, health sciences or equivalent degree/experience; RN or pharmaceutical experience preferred but not required.
  • Minimum of 4 years of clinical trial management and 2+ years clinical research associate with on-site/remote clinical monitoring experience in biotech/pharma/CRO.
  • Minimum of 2 years directly managing, coaching, and developing clinical operations professionals (e.g., Sr. CRAs, CRAs, CTAs).
  • Robust understanding of ICH/GCP and regulatory requirements.
  • Working knowledge of medical terminology.
  • Experience with medical laboratory testing and documentation of patient information.
  • Comfortable with technology and scientific/engineering principles.

Skills

Required:Critical thinking and problem solvingClinical study/project managementCommunication and leadershipIndependent work and initiativeMentoring and staff developmentFDA regulations and GCP knowledgeMicrosoft Office, EDC systems, eTMF, CTMS

Benefits

  • 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
  • Living Donor Employee Recovery Policy offering up to 30 days of paid leave for organ/bone marrow donation
  • Detailed benefits page at caredx.com/company/careers
Last updated Jul 29, 2026. Interested? Apply on the company site.
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About CareDx

Together in Transplant

CareDx delivers transplant-focused diagnostics, digital health tools, and services that support patients and clinicians across the entire transplant journey.

DiagnosticsDigital HealthTransplant
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