Clinical Trial Manager

Job not on LinkedIn

🔥 31 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $124k - $155k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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CareDx, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

<CareDx, Inc. > CareDx, Inc. is a healthcare-focused company that develops diagnostic tests, laboratory services, and digital solutions specifically for transplant patients and providers. Its offerings include cell-free DNA tests (AlloSure) for monitoring organ injury, HLA typing products for matching, transplant lab services, digital patient management apps and EMR integrations, and pharma services to support clinical development. CareDx serves transplant centers, clinicians, patients, and biopharma partners to improve organ transplant outcomes across kidney, heart, and lung care.

📋 Description

• Lead end-to-end execution of CareDx clinical trials from site identification and study start-up through conduct, monitoring, and closeout • Own study timelines, budgets, metrics, IRB/EC submissions, study documents, and study-specific meetings • Drive site activation, enrollment, and overall study performance • Identify study risks, lead mitigation plans, and escalate operational issues with action plans and accountability • Review investigator contracts and payments as needed • Coordinate Clinical Operations, Data Management, Medical Affairs, and other functions • Prepare and present project debriefings to management and cross-functional teams • Oversee Clinical Research Associates, CROs, central labs, and external vendors using governance, KPIs, and performance management • Standardize study execution, optimize vendor management and reporting, and implement process improvements and SOPs • Ensure data quality and inspection readiness through data review, metric tracking, and collaboration with monitoring and data management teams • Maintain communication with clinical sites and stakeholders, oversee site visits and documentation, and ensure GCP, regulatory, and protocol compliance • Support site engagement, training, and product inventory management • Maintain complete, high-quality eTMF documentation and real-time study status reporting • Oversee CTMS use for study milestones, enrollment, monitoring activities, and performance metrics • Directly lead and manage clinical operations personnel • Travel approximately 10–30%

🎯 Requirements

• Bachelor’s degree in life sciences, health sciences or equivalent degree/experience • Minimum of 4 years of clinical trial management experience • 2+ years of clinical research associate experience with on-site/remote clinical monitoring in the biotechnology/pharmaceutical/CRO industry • Minimum of 2 years directly managing, coaching, and developing clinical operations professionals • Robust understanding of ICH/GCP and knowledge of regulatory requirements • Working knowledge of medical terminology • Experience with medical laboratory testing and documentation of patient information • Comfortable with technology and scientific/engineering principles • Strong clinical study/project management skills • Strong communication, written, organizational, problem-solving, conflict-resolution, leadership, and team-building skills • Ability to work independently, take initiative, and meet goals within timelines and budget • Ability to mentor staff, drive accountability, manage priorities, and support clinical study execution • Ability to work across time zones and manage competing tasks • Strong knowledge of FDA regulations and GCP • Proficiency in Microsoft Office, EDC software such as Medrio and Medidata, eTMF, CTMS, and safety-report platforms • RN or pharmaceutical experience preferred but not required • Experience with organ-transplantation clinical studies preferred

🏖️ Benefits

• Competitive base salary and incentive compensation • Health and welfare benefits • Gym reimbursement program • 401(k) savings plan match • Employee Stock Purchase Plan • Pre-tax commuter benefits • Up to 30 days of paid leave annually for a full-time employee who donates an organ or bone marrow • Additional discretionary bonuses/incentives and restricted stock units may be available

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