The Clinical Laboratory Manager will be responsible for core lab operations in a high volume clinical reference laboratory.
He / she will direct the technical day-to-day laboratory operation which includes the general technical supervision and development of laboratory mangers / supervisors, assures that quality standards are being met, provides technical expertise to the laboratory and as needed, serves as the liaison to various internal and external entities.
The Clinical Laboratory Manager ensures that the laboratory and the laboratory staff is in compliance with all laws and regulations that are required by CLIA, CAP, OSHA and any other applicable legislative organizations.
Essential Duties and Responsibilities :
Duties may include but are not necessarily limited to the following :
- Be a proactive leader and identify opportunities and propose improvements, efficiencies and operational modification as it relates to the laboratory
- Responsible for scientific oversight of the laboratory including review / approval of all SOP's.
- Identify and understand regulatory requirements to ensure the laboratory is in compliance with all applicable laws and regulations pertinent to the management of the laboratory, including applicable CLIA, CAP and other requirements and regulations for states in which the lab is licensed
- General maintenance of a CLIA-certified diagnostic laboratory, including responsibilities for pre-analytic operations and technical analysis
- Collaborates with management to optimize overall workflow of the Clinical Laboratory
- Maintains adequate staffing and performs scheduling, planning, and monitoring of workflow based on patient load to meet established goals
- Procures appropriate supplies and equipment to maximize efficiency within established budgetary and quality goals
- Supports, implements, and ensures compliance with all departmental and company policies and procedures including but not limited to Quality and Safety
- Oversees the training, supervision and work schedules of all Laboratory personnel
- Responsible for the evaluation training, and competency of all testing personnel
- Prioritizes responsibilities, anticipates problems and provides timely and appropriate solutions.
- Ability to liaison with other operational areas including sales and logistics
- Responsible for validating and implementing new methods and technologies
- Technical responsibilities : Verify the test procedures performed and establish the laboratory's test performance characteristics, including precision and accuracy of each test and test system Ensure that the quality management program is maintained by following parameters for acceptable performance for the pre-analytical, analytical and post-analytical testing processes Resolve all 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 Ensure that all patient results are not reported until corrective actions have been taken and the systems are functioning properly Identify training needs and ensures all training is performed as required
Required Education & Experience :
- BSMT or BS Degree in one of the life sciences (Biology, Chemistry, etc.), Clinical Lab Science, or in Medical Technology
- Minimum of six years of post-bachelor's degree experience as a medical technologist or equivalent within a high complexity clinical laboratory setting
- Minimum of two years of previous laboratory management experience with a strong operational background in all aspects of Laboratory operations
- ASCP certification or equivalent is desired
Required Skills & Qualifications :
- Proven experience in the areas of laboratory supervision, Laboratory Information's System (LIS) requirements and workflow needs and technical capabilities
- Experience working with Quality Management including 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
- Excellent professional communication skills, including verbal, written, and presentation
- Excellent collaboration skills, with the ability to positively influence others
- Strong leadership skills; able to support and demonstrate company mission, and perform as a team member and leader
- Strong strategic, and proactive thinking skills; able to make and support decisions
- Strong scientific and analytical skills
- Computer proficient with multiple software programs, including MS Office Suite, and Laboratory Management Systems