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
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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
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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The U.S. EEO posters are available here
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Note: We do not accept resumes from headhunters, placement agencies, or other
suppliers that have not signed a formal agreement with us.
#LI-Remote
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. Base pay is one part of the Total Package
that is provided to compensate and recognize employees for their work, and this
role may be eligible for additional discretionary bonuses/incentives and
restricted stock units. CareDx is a multi-state employer, and this salary range
may not reflect positions that work in other states.
San Francisco Bay Area Roles
$124,000—$155,000 USD
This is the anticipated base salary range in the United States. 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. Base
pay is one part of the Total Package that is provided to compensate and
recognize employees for their work, and this role may be eligible for additional
discretionary bonuses/incentives and restricted stock units. CareDx is a
multi-state employer, and this salary range may not reflect positions that work
in other states.
Remote: US only roles
$112,000—$140,000 USD
