Clinical Trial Manager

CareDx, Inc.

. Lead end-to-end execution of CareDx clinical trials from site identification and study start-up through conduct, monitoring, and closeout .

Posted 11/4/2026full-timeRemote • California • United StatesMid-LevelSenior💰 $124,000 - $155,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including end-to-end execution, site activation, and compliance with ICH/GCP and FDA regulations. Proficient in managing clinical operations teams, optimizing vendor management, and ensuring data quality and inspection readiness.

Highest-signal resume keywords

Clinical Trial ManagementICH/GCP ComplianceProject ManagementClinical Operations LeadershipVendor Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementRegulatory RequirementsMedical TerminologyData Quality AssuranceClinical MonitoringBudget ManagementRisk MitigationStudy DocumentationPerformance MetricsOrgan-Transplantation Studies

Soft Skills

Strong CommunicationProblem-SolvingLeadershipTeam-BuildingConflict Resolution

Tools & Technologies

Microsoft OfficeEDC SoftwareMedrioMedidataETMFCTMSSafety-Report Platforms

Certifications & Qualifications

Bachelor’s Degree in Life SciencesRN or Pharmaceutical Experience (Preferred)

Industry Keywords

BiotechnologyPharmaceuticalCROClinical ResearchClinical Operations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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