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.
CareDx is seeking a dynamic and technical Senior Manager, IT LIMS & Analytics leader to join our IT team. As Senior Manager, IT LIMS & Analytics, you will be responsible for overseeing the day-to-day operational support, maintenance, users SLA, resource management, and technical operations of our LIMS and Lab Analytics systems and environment. This environment consists of several instances of LIMS (StarLIMS), workflows, data warehouses, Relational Database Management Systems (SQL RDBMS), Mongo DB, Azure, integrations with laboratory instruments, electronic medical records, portals, various other software, and data analytics systems.
This IT leader will partner with the Software development, lab operations team, multiple stakeholders, SQA, IT, and Cybersecurity teams to continuously improve the LIMS and integrations with the rest of the systems within the enterprise. This role ensures the stability, performance, and security of the LIMS, facilitating seamless operations and compliance with regulatory standards such as FDA – 21 CFR part 820, GMP, CLIA, CAP, EUMDR, SOX, HIPPAA, and ISO. The ideal candidate will have a strong background in large-scale systems development in a highly regulated environment, laboratory information management systems, production support, and team leadership.
Responsibilities:
- Production Support Management:
- Oversee the day-to-day operations and support of the StarLIMS and RDBMS environments.
- Participate in daily support of the system and ensure timely resolution of incidents, service requests, SLAs, and issues related to the LIMS.
- Monitor system performance and implement improvements to enhance reliability, efficiency, ease of use, and cybersecurity.
- Actively participate, lead, own, and manage system upgrades, patches, and enhancements in collaboration with the Software Development, vendors, and internal stakeholders.
- Integration and Collaboration:
- Coordinate with other teams to ensure seamless integration of the LIMS with electronic medical record systems, revenue cycle management systems (Telcor), laboratory instruments, Faxing software, care portals, and analytics systems.
- Collaborate with laboratory operations and other departments to understand their needs and ensure the LIMS environment supports their workflows effectively.
- Compliance and Quality Assurance:
- Ensure the environment complies with applicable regulatory requirements, including SOX, HIPAA, FDA, CAP, CLIA, ISO, and other relevant standards.
- Develop and maintain documentation, including standard operating procedures (SOPs), workflows, and system configurations.
- Conduct regular audits and reviews to ensure data integrity and system accuracy.
- Team Leadership:
- Lead and mentor a team of LIMS support specialists.
- Foster a culture of customer focus, continuous improvement, collaboration, and accountability within the team.
- Provide training and development opportunities to enhance team capabilities.
- Lead by example.
- Stakeholder Management:
- Serve as the primary point of contact for LIMS-related inquiries and escalations.
- Communicate effectively with internal stakeholders, including laboratory staff, IT teams, and management, to address concerns and provide updates on system status and initiatives.
- Engage with external vendors and service providers to ensure optimal system performance and support
- Other duties as assigned.
Qualifications:
- Bachelor’s degree in Information Technology, Computer Science, Life Sciences, or a related field. Master’s Degree preferred.
- Minimum of 7 years of hands-on experience in managing LIMS (StarLIMS preferred) or similar systems in a healthcare or diagnostics environment.
- Experience in setting up and management of SQL (Oracle or MS SQL) programs and scripts in public and private cloud environments.
- Proven experience in large scale LIMS development, and production support of systems, including establishingoptimal support processes, key performance metrics and use of service management systems such as ServiceNow.
- Experience in establishing and maintaining system integrations.
- Strong understanding of and experience operating in regulatory (SOX, HIPAA, CAP, CLIA, FDA, EUMDR, ISO) environments and best practices for laboratory information systems.
- Customer focused with excellent team leadership, problem-solving, communication, and interpersonal skills.
- Ability to manage multiple priorities and work effectively in a fast-paced environment.
- Must be a critical thinker, self-starter, and independent problem solver in ambiguous situations.
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.
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