Senior Manager, IT LIMS
3 weeks ago
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. Our company 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.
We are 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.
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.
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