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. 

The Manager, Pre-Analytical plays a vital role in overseeing clinical laboratory operations at CareDx, ensuring the efficient management of specimens from receipt to processing. Responsibilities include supervising personnel, managing specimen kit receipt processes, order processing, sample handling, and document management. The Manager, Pre-Analytical also contributes to shift scheduling, troubleshoots technical and non-technical issues, and provides coaching and mentoring to foster effective teamwork and achieve project goals. This role emphasizes hands-on involvement in sample accessioning up to 50% of the time, particularly during peak volume days or staff absences. Acting as a liaison between specimen handling, customer services, and various laboratory departments, the Manager coordinates specimen receipt and tracking to ensure seamless communication and collaboration. The ideal candidate will have experience with Laboratory Information Management Systems (LIMS) and Electronic Medical Records (EMR), as well as demonstrated proficiency in managing clinical lab operations. Furthermore, the position entails developing SOPs, establishing quality and operational metrics, analyzing trends, and implementing process improvements to enhance efficiency and quality standards. This role reports to the Senior Manager, Clinical Lab Operations and is based in Brisbane, California. 
 
Responsibilities: 

• Supervise the overall operation of the Clinical Laboratory Support function.
• Oversee safety, ergonomics, maintenance, and Lean/Visual Management of department (including upgrades, repairs, continuous improvement, etc.)
• Establish and motivate a participative work environment that actively encourages and supports employee involvement
• Ensure day-to-day staffing and scheduling for the accessioning and laboratory support function meets requirements; assist with accessioning on peak days and during staff absences.
• Maintain consistency in work completion according to department goals and standard operating procedures.
• Partner with other members of laboratory management team to hire shared staff; oversee training on accessioning and laboratory support activities for new hires in collaboration with the laboratory supervisors.
• Collaborate with Clinical Operations to organize sample logistics and track incoming samples for testing in studies.
• Develop and maintain standard operating procedures (SOPs) related to specimen intake and accessioning.
• Lead projects pertaining to specimen stability, validation protocols, new products, new clinical studies, and other process improvements.
• Handle employee issues that relate to accessioning and laboratory support, collaborating with laboratory supervisors and management to resolve issues.
• Provide input to performance management for accessioning staff.
• Develop and track quality and operational metrics; present data at weekly, monthly and quarterly operations and quality meetings; recommend and implement process improvements.
• Investigate and document accessioning errors and non-conformances; initiate and manage CAPAs as necessary.
• Follow the laboratory's procedures for pre-analytical specimen handling and processing while participating in the continuous quality-improvement processes.
• Collaborate with the product development and software engineering teams to enhance the LIMS capabilities for accuracy and scale.
• Manage LIMS access for specimen accessioning.
• Ensure compliance with all regulatory agency requirements.
• Other duties as assigned.

Shift: Monday - Friday (Flexibility to start between 7-10am) OR Tuesday – Saturday 10:00am – 6:30pm 

Qualifications: 

• Bachelor’s degree in life sciences, or equivalent combination of science education and work experience.
• 5 years of related experience in a clinical laboratory environment. Working knowledge of CLIA, CAP, California and New York quality system principles related to specimen collection, receipt and handlingrequired.
• 3 years of supervisory experience in a CLIA lab environment and strong leadership skills to foster a high performance, teamwork-oriented laboratory environment.
• Strong interpersonal skills and high communication proficiency both verbal and written, in technical and non-technical domains.
• Proficiency in Laboratory Information Management Systems (LIMS), Electronic Medical Records (EMR), and clinical specimen managementrequired.
• Strong computer skills, including proficiency in Microsoft Officeand ability to monitor key metrics and generate quality and operational reports.
• Experience managing logistical operations and coordinating with shipping carriers such as UPS and FedEx preferred.
• Strong desire and proven ability to work collaboratively and cross functionally on company initiatives.
• Experience leading improvement projects to achieve process efficiencies and scale the accessioning function to build capacity.
• Demonstrated task leadership with timely achievement of goals.

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 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!

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 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 Noticeand consent to receive email communication from CareDx. 

******** We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us. 

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