Manager, Clinical Laboratory

• 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, establish 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.

In specific locations, the pay range may vary from the range posted.