Manager, Clinical Laboratory, 3rd shift

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At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

The Manager, Clinical Laboratory manages the overall daily clinical laboratory operations and develops procedures to ensure safety, quality, and accuracy of results. This position oversees the supervision and development of laboratory staff, provides technical expertise to the laboratory, and serves as the liaison to internal and external entities. In addition, the Manager, Clinical Laboratory oversees the quality management program within the clinical laboratory and ensures that the laboratory is in compliance with all laws and regulations required by CLIA, CAP, OSHA, New York, and any other applicable state or federal legislative organizations.

The Manager, Clinical Laboratory collaborates with various departments and cross-functional teams to ensure the quality and timeliness with which patient and clinical validation study samples are processed, and is accountable for the laboratory team’s deliverables on designated product development and process development projects.  The Manager, Clinical Laboratory facilitates timely and effective communication with other departments regarding service coverage needs and resolution of issues related to commercial patient samples, adjusting laboratory staffing levels, as needed.

The Manager, Clinical Laboratory may perform high complexity laboratory testing on patient specimens, interprets and reports patient results, and troubleshoots high complexity technical and non-technical problems.

Schedule:

• Tuesday – 8:00am – 4:30pm
• Wednesday – Friday – 1:00pm – 12:00am

Essential Duties

Include, but are not limited to, the following:

• Directs the daily workflow of the clinical laboratory departments; including, but not limited to, ensuring processing systems for patient and study samples are functioning properly, monitoring quality control testing results, and monitoring quality assurance performance metrics.
• Manages designated laboratory and cross-functional projects such as process improvements, quality improvements, clinical validation studies, and the development and launch of new products.
• Collaborates with Exact Sciences’ human resources department and participates in the employee hiring and management process by interviewing candidates, hiring, and employee counseling.
• Assesses scheduling needs of the departments to ensure adequate coverage to meet service needs.
• Identifies and understands regulatory requirements to ensure that the laboratory complies with all applicable state and federal laws and regulations pertinent to the management of the laboratory; including applicable CLIA, CAP, and other requirements and regulations such as California and New York (CLEP) laboratory programs.
• Manages the inspection preparation activities in the clinical laboratory, such as maintaining consistent, ongoing readiness for inspections and representing the clinical laboratory during inspections.
• Provides or delegates responsibility of supervision of the clinical laboratories and is accessible to the laboratory personnel to provide on-site, telephone, or electronic consultation.
• Maintains a process for staffing, recruiting, training, evaluating competency, and ongoing employee development.
• Works strategically with department supervisors and managers to ensure testing is completed within turnaround time.
• Partners with senior management in establishing strategic priorities and annual quality indicators.
• Collaborates with the laboratory leadership to assist in developing and providing continuing education credits for the laboratory staff.
• Ensures staff are properly trained and competent in all aspects of their job duties and departmental procedures.
• Reviews, writes, and updates standard operating procedures (SOPs).
• Reviews and writes nonconformance and deviation approval requests, and other documents, as appropriate.
• Possesses effective management skills to supervise department staff and maintain departmental budgets.
• Provides oversight to ensure prompt, accurate, and timely processing, and delivery of all patient specimens.
• Evaluates equipment and supply needs of the laboratory.
• Works with the laboratory leadership to maintain operations within the budget.
• Assures timely and appropriate ordering of supplies and equipment.
• Partners with the laboratory supervisors to monitor supply usage and variances.