Manager, Clinical Operations

About the Role

The Manager of Clinical Operations is responsible for the technical operations of the Clinical Laboratory. The Manager monitors patient and quality control testing results, writes and reviews standard operating procedures, addresses technical issues and takes remedial action when needed. The Manager ensures laboratory staff are correctly trained on all processes and supervises both licensed and unlicensed laboratory team members. As a leader of the Clinical Operations function as well, the Manager will be responsible for supervision of the laboratory staff. The Manager demonstrates good judgment, sound analysis and decision making, the ability to remain professional and composed under pressure and the ability to communicate effectively across levels and functions. The Manager will ensure that the Clinical Lab team adheres to CLIA and CAP standards. The Manager complies with all applicable local, state and federal laboratory requirements and operates under the direction of the Laboratory Director and Director of Clinical Operations.

Essential Duties and Responsibilities

• Accurately monitor molecular testing
• Conduct and oversee daily quantitation and qualification assessment of molecular data generated during testing
• Lead a variety of other essential 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 the Accessioning Supervisor on the laboratory’s 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 cause and document all corrective actions taken with test systems
• Oversee training and competency of new and existing laboratory personnel
• Manage stability study, validation protocols, and other process improvement and new assay projects
• Participate in audits and inspections
• Perform biennial review of Standard Operating Procedures
• Participate in introduction of assay improvements, new assay configurations and validation
• Support the Clinical Operations team and be responsible for the daily operations of the laboratory including but not limited to scheduling, independently troubleshooting and resolving technical and non-technical high complexity problems
• Report all concerns of test quality and/or safety to the Laboratory Director or Safety Officer.

Essential Qualifications

• Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field
• At least eight years of Clinical Laboratory experience or equivalent high complexity and volume laboratory experience preferred
• At least two years of supervisory experience preferred
• Working knowledge of local, state, and federal laboratory regulations
• Working knowledge of FDA QSR and ISO 13485 requirements a plus
• Laboratory experience within the last year preferred
• Experience in molecular biology techniques preferred
• Strong working knowledge of local, state, and federal laboratory regulations
• Able to integrate and apply feedback in a professional manner
• Ability to manage daily test processing needs with high emphasis on quality
• Ability to analyze and problem solve basic issues that impact test performance
• Ability to work as part of a team
• Strong computer and automation skills
• Ability to proactively communicate consistently, clearly, and honestly
• Outstanding professionalism, leadership, and communications skills
• Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed
• Ability to provide direct supervision to laboratory personnel
• Strong project management abilities.

Work Environments

Hours and days may vary depending on operational needs; Standing or sitting for long periods of time may be necessary; May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high-speed centrifugation; May be required to lift routine office supplies and use office equipment; Majority of the work is performed in a desk/office environment; and Ability to sit for extended periods of time.

AI & Digital Fluency

Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.