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.
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.
Specific responsibilities include, but are not limited to:
- 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.)
- 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.
- Provide oversight and operational support for CTMS system and effective use of it for tracking study milestones, enrollment, monitoring activities, and performance metrics.
- Directly leading and managing clinical operations personnel.
Minimum Qualifications
- Education: 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.
- Minimum of 2 years directly managing, coaching, and developing clinical operations professionals (e.g., Sr. CRAs, CRAs, CTAs, etc.), including workload management, performance development, and cross-functional collaboration.
- 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 collaborated with teams at other functional departments.
- Ability to work independently, take initiative, and meet company goals within timelines and budget.
- Ability to mentor staff, drive accountability, manage priorities, and support the successful execution of clinical studies.
- 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.
- Ability 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.
SCOPE OF WORK
- Travel estimate 10-30% .
- Operate within standard guidelines, but must engage in some independent decision-making.
- Errors that are not quickly detected and rectified could have a significantly adverse effect on the quality of the study.
- Works closely with other Clinical Research staff, as well as staff from other departments.
PREFERENCES
- Experience with clinical studies involving organ transplantation.
Additional Details:
Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.
Our competitive Total Rewards package for US Employees includes:
- 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
- And more!
- Please refer to our page to view detailed benefits at https://caredx.com/company/careers
In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.
With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.
CareDx, Inc. is an Equal Opportunity Employer-vets/disabled, and participates in the E-Verify program. By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from CareDx. Certain jurisdictions require notice of how we use and protect your personal information. For more information, please read our Privacy Policy
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