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.

Shift: Weekend PM

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.

• Reviews test volumes with laboratory leadership to develop and implement timely changes to manage workload.

• Verifies test procedures performed, and with assistance, establishes the laboratory’s test performance characteristics, including precision and accuracy of each test and test system.

• Ensures that the quality management program is maintained by following parameters for acceptable performance for the pre-analytical, analytical, and post-analytical testing processes.

• Resolves high complexity technical problems, with the aid of the technical staff and ensures that remedial action is taken whenever a test deviates from the laboratory’s performance standards.

• Ensures that all patient results are not reported until corrective actions have been taken and the systems are functioning properly.

• Identifies training needs and ensures all training is performed, as required.

• Assists with the training of new laboratory personnel and training of new procedures with existing personnel, as needed.

• Evaluates competency of all laboratory personnel.

• Supervises staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.

• Communicates goals clearly to employees to ensure understanding and success in achieving them.

• Motivates and inspire employees to do their best work through coaching and mentoring.

• Maintains morale and supports employee engagement initiatives.

• Excellent customer service skills.

• Ability to work well with all members throughout the organization.

• Excellent verbal and written communication skills.

• Excellent presentation skills, including public speaking.

• Excellent analytic skills.

• Ability to organize work and meet deadlines.

• Excellent time management skills.

• Ability to effectively evaluate situations and work with teams to develop appropriate resolutions.

• Ability to quickly implement and adapt to change.

• Ability to apply project management skills to leadership of operational expansion and process improvements.

• Ability to quickly and calmly adapt and respond to changes in priorities, timelines, and deliverables.

• Ability to communicate clearly and effectively in writing and verbally to technical and non-technical audiences.

• Ability to integrate and apply feedback in a professional manner.

• Ability to prioritize and drive to results while maintaining a consistently high-quality standard.

• Ability to work as part of a team.

• Upholds company mission and values through accountability, innovation, integrity, quality, and teamwork.

• Supports and comply with the company’s Quality Management System policies and procedures.

• Maintains regular and reliable attendance.

• Ability to act with an inclusion mindset and model these behaviors for the organization.

• Ability to work designated schedule.

• Ability to work nights and/or weekends.

• Ability to move 40 pounds for approximately 25% of a typical working day.

• Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day.

• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day

• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height, ability to stand, bend and transfer materials

• Ability to comply with any applicable personal protective equipment requirements

• Ability to use various types of laboratory equipment including microscopes, microtomes, blades, strainers, pipettes for extended periods of time.

• Ability to perform repetitious actions using lab tools.

• Ability to use near vision to view samples at close range.

• May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.

Minimum Qualifications

• Bachelor’s Degree in Chemical, Biological, or Clinical Laboratory/Medical Technology Science or field related to the essential duties.

• 6+ years of experience working in a clinical laboratory setting.

• 3+ years of experience leading and managing teams.

• Demonstrated ability working in a high-volume laboratory operations environment.

• Demonstrated ability working with quality management programs.

• Strong working knowledge in the areas of laboratory technology, management principles, laboratory information system (LIS) management, and workflow needs and capabilities.

• Strong knowledge of all laws and regulations that are required by CLIA, CAP, OSHA, and other related legislative and/or state health departments and organizations.

• Proficient in Microsoft Office.

• Authorization to work in the United States without sponsorship.

• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• Advanced Degree.

• 4+ years of experience with LIS requirements and workflow needs.

• 4+ years of experience working with quality management; including strong knowledge of all laws and regulations that are required by CLIA, CAP, OSHA, New York, and other related legislative and/or state health departments and organizations.

• Experience with one or more standard molecular biology techniques such as nucleic acid isolation, RNA/DNA quantification, PCR and RT-PCR, and DNA sequencing.

• Experience with high-throughput robotic instruments.

• Familiarity with FDA regulations of Laboratory Developed Tests (LDT).

• Familiarity with ISO standards.