Manager, Clinical Operations
About The Position
The Manager of Clinical Operations is responsible for technical operations and daily laboratory operations within the Clinical Laboratory. The role monitors patient and quality-control testing results; writes and reviews standard operating procedures; addresses technical issues and takes remedial action; and ensures laboratory staff are properly trained. The Manager supervises licensed and unlicensed laboratory personnel and ensures the Clinical Lab team adheres to CLIA and CAP standards and applicable local, state, and federal laboratory requirements. The position operates under the direction of the Laboratory Director and Director of Clinical Operations. The Manager exercises sound judgment and analysis, makes decisions, remains professional and composed under pressure, and communicates effectively across levels and functions. The role also requires curiosity and sound judgment in critically evaluating and responsibly using AI-enabled tools in line with company policies, ethical standards, and regulatory requirements. The position is primarily performed in a desk/office environment, with potential exposure to laboratory hazards. For U.S. employees who live within 50 miles of a Guardant facility and are eligible for hybrid work, onsite collaboration is scheduled for Mondays, Tuesdays, and Thursdays, with work-from-home days for individual-focused work. Hours and days may vary according to operational needs.
Requirements
- Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science, or a related field.
- Working knowledge of local, state, and federal laboratory regulations.
- Ability to integrate and apply feedback professionally.
- Ability to manage daily test-processing needs with a strong emphasis on quality.
- Ability to analyze and solve basic issues that affect test performance.
- Ability to work as part of a team.
- Strong computer and automation skills.
- Ability to communicate proactively, consistently, clearly, and honestly.
- Professionalism, leadership, and communication skills, including maintaining open communication with employees, managers, and customers as needed.
- Ability to directly supervise laboratory personnel.
- Strong project management abilities.
- Ability to critically evaluate and responsibly use AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements.
Nice To Haves
- At least eight years of clinical laboratory experience or equivalent high-complexity, high-volume laboratory experience is preferred.
- At least two years of supervisory experience is preferred.
- Knowledge of FDA QSR and ISO 13485 requirements is a plus.
- Laboratory experience within the last year is preferred.
- Experience with molecular biology techniques is preferred.
Responsibilities
- Accurately monitor molecular testing.
- Conduct and oversee daily quantitation and qualification assessment of molecular data generated during testing.
- Lead laboratory activities including reagent qualification, inventory management, procedure writing, inspection preparation, assay validation, and investigation.
- Work with the Clinical Laboratory General Supervisor, Technical Supervisor, and Accessioning Supervisor on quality control and quality assurance procedures, technical troubleshooting and improvement procedures, reagent manufacturing, and training and education programs.
- Review and document routine preventive maintenance and independently identify and troubleshoot highly complex problems that adversely affect test performance.
- Identify root causes and document corrective actions taken with test systems.
- Oversee training and competency of new and existing laboratory personnel.
- Manage stability studies, validation protocols, process improvement projects, and new assay projects.
- Participate in audits and inspections.
- Perform biennial reviews of Standard Operating Procedures.
- Participate in introducing assay improvements, new assay configurations, and validations.
- Support the Clinical Operations team and manage daily laboratory operations, including scheduling and independently troubleshooting and resolving high-complexity technical and non-technical problems.
- Report concerns about test quality or safety to the Laboratory Director or Safety Officer.
- Ensure staff training and adherence to applicable laboratory standards and requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
