Clinical Trial Manager

About the role

CareDx, Inc. is seeking a Clinical Trial Manager (CTM) to provide direction and operational leadership of clinical trials. The CTM will manage clinical trials from study start-up activities through the clinical study report, ensuring the highest level of data quality and compliance.

Responsibilities

• Lead the end-to-end execution of CareDx clinical trials, including site identification, study start-up, study conduct, monitoring and closeout, with full accountability of study timelines, budget and metrics;
• Study submission to IRB/ECs;
• Study document development and review (training documentation, ICF, study specific plans, eCRF Guidelines, lab test requisitions, etc.), plans and managing study-specific meetings (e.g. Study Team Meetings, Investigator meetings, etc.).
• Drive site activation, enrollment, and overall study performance while ensuring alignment with protocols, operational plans, and business objectives;
• Proactively identify study risks (timeline, quality, and operational), lead mitigation planning and execution, and escalate issues effectively with clear action plans, defined ownership, and accountability;
• Conduct internal review of investigator contracts and payments, as necessary;
• Provide cross-functional leadership across Clinical Operations, Data Management, Medical Affairs and other functional areas serving as the central point of coordination to ensure clear roles, accountability, and seamless clinical trial execution;
• Prepare and present project debriefings to Clinical Operations management and cross-functional teams;
• Oversee Clinical Research Associates, CROs, central labs, and external vendors to ensure high-quality, timely, and cost-effective deliverables through established governance, KPIs, and performance management processes;
• Champion operational excellence by standardizing study execution models, optimizing vendor management and reporting frameworks, and implementing scalable process improvements and SOPs;
• Ensure data quality and inspection readiness through proactive data review, performance metric tracking, and close collaboration with monitoring and data management teams. Identify and mitigate risks across timelines, quality, and operations, driving effective escalation and resolution strategies;
• Maintain strong communication with clinical sites and stakeholders, including oversight of site visits, study documentation, and reporting, while ensuring compliance with GCPs, regulatory requirements, and study protocols;
• Support study administration activities such as site engagement, training, and product inventory management to ensure efficient and compliant study execution;
• Ensure high-quality, inspection-ready documentation and study tracking through effective use of eTMF including oversight of TMF completeness, document quality, and real-time study status reporting;
• Oversee and operational support for CTMS system and effective use of it for tracking study milestones, enrollment, monitoring activities, and performance metrics.

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 the biotechnology/pharmaceutical/CRO industry;
• 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.

Skills and Experience

• A critical thinker and capable of problem solving and aligning the priorities with study outcomes and timelines;
• Strong clinical study/project management skills;
• Excellent communication, written and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict resolution, leadership and team-building skills;
• Ability to motivate and collaborate with teams at other functional departments;
• Able to work independently, take initiative, and meet company goals within timelines and budget;
• Able to work in a fast-paced environment with multiple competing tasks and demands, across time-zones;
• Must have a sense of urgency about problem-solving and completing projects;
• Able to communicate with vendors and keep a high quality of clinical study;
• Strong knowledge of FDA regulations and GCP;
• Proficient in Microsoft Office (excel, word, outlook, power point), electronic data capture (EDC) software (Medrio, Medidata) and other platform related to electronic Trial Master File (eTMF), CTMS and safety report.

Preferences

• Experience with clinical studies involving organ transplantation.

Benefits

Competitive total rewards package including competitive base salary and incentive compensation, health and welfare benefits, 401(k) savings plan match, Employee Stock Purchase Plan, pre-tax commuter benefits, and more!

Pay

This is the anticipated base salary range for candidates who will work in Brisbane, California. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc.

Schedule

Remote: US only roles