Clinical Trial Manager

About this role

<div class="content-intro"><p><span style="font-family: times new roman, times, serif;"><span style="font-size: 16px;"> </span></span></p></div><p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.</span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">This position provides direction and operational leadership of the clinical research studies to ensure delivery on time. The Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The CTM drives completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates and resolves clinical study operational issues; and participates in process improvement initiatives as required.</span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;"><strong>Specific responsibilities include, but are not limited to:</strong></span></p> <ul> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Lead the end-to-end execution of CareDx clinical trials, including but limited to 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.)</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Drive site activation, enrollment, and overall study performance while ensuring alignment with protocols, operational plans, and business objectives.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Conduct internal review of investigator contracts and payments, as necessary.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Prepare and present project debriefings to Clinical Operations management and cross-functional teams.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Champion operational excellence by standardizing study execution models, optimizing vendor management and reporting frameworks, and implementing scalable process improvements and SOPs.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Maintain strong communication with clinical sites and…