The Manager of Histology, Clinical Operations is responsible for the technical operations of the Histology Laboratories for the TissueNext Program. 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. The Manager will be responsible for supervision of the histotechnician 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 Histology Production 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 Senior Director of Biospecimen Management.Essential Duties and Responsibilities:Accurately monitor histology testing;Conduct and oversee daily data generated during testing and generate monthly longitudinal monitoring metrics; Lead a variety of other essential laboratory activities, including inventory management, procedure writing, inspection preparation, assay validation and investigation;Work with the Clinical Operations, Client Services, Reporting, and Software Enterprise Departments 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;Writes and reviews standard operating procedures, performs other administrative duties including but not limited to: writing and reviewing employee performance evaluations, protocols, clinical trial sample tracking and equipment maintenance formsIdentify 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;May oversee the tissue biospecimen management team operationsManages and leads department projects and goalsPerform biennial review of Standard Operating Procedures;Participate in introduction of assay improvements, new assay configurations and validation;May represent the Biospecimen Management and Histology Department in cross functional meetingsSupport the Tissue Clinical Operations team and be responsible for the daily operations of the biospecimen management and histology laboratories 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 Senior Director, Laboratory Director or Safety Officer.
