Provide leadership and direction to the clinical operations team overseeing clinical laboratory testing, the quality system of the laboratory and study execution, including planning and implementation of a new cytology laboratory. Responsible for financial management, productivity, quality and service, strategic planning, continuous improvement, staff development and management, procedures, and developing and implementing new services. Completes special assignments as assigned by the Laboratory Director and/or COO.
Essential Functions/Responsibilities (other duties may be assigned):
Responsible for the management of the laboratory
Directs and coordinates laboratory activities to ensure that services are provided on schedule within quality and cost objectives
Establishes laboratory organization and process plans and delegates responsibilities, authorities, and accountabilities to appropriate staff
Creates development and training plans for supervisory personnel within the laboratory
Directs, coordinates, and oversees major unit projects to the best economic advantage of True Health Diagnostics LLC
Monitors and responds to monthly volumes, utilization, financial, operational and quality metrics
Collaborates with the Executive Team on any issue that affects the quality, performance, scaling, etc. of the scientific community of True Health Diagnostics.
Takes action on personnel and operational issues with urgency
Works collaboratively with and provides leadership to the other True Health business units
Manages human resource related functions
Provides timely performance feedback and completion of scheduled performance appraisals of supervisory personnel
Responsible for justification, interviewing and hiring of new employees
Develops an environment for personal growth, development and learning for employees by encouraging continuing education, special projects etc.
Actively coaches, mentors and develops employees
Implements and supports True Health Quality Assurance Program and regulatory compliance
Ensures that all laboratory activities and operations are carried out in compliance with local state, federal, and governmental regulations and laws
Adhere to and uphold all applicable federal and state compliance regulations as well as True Health’s Code of Conduct and Ethical Responsibility, compliance policies and procedures, and applicable healthcare fraud, waste and abuse laws. Ensure adherence to these compliance standards among all True Health colleagues for whom I am responsible to manage and oversee.
Ensures documentation, correction, and follow-up of quality and safety events
Responsible for internal/external audits
Identifies opportunities for improvement and utilizes continuous improvement methods in problem-solving to achieve desired outcomes
Oversees troubleshooting and documentation of equipment, tests, results, etc.
Oversees training of employees and trainees
Ensures adequate training of personnel including documentation of training
Meets with and/or trains employees and trainees
Creates and maintains a patient service focus within the laboratory
Coordinates the training of employees in customer service, diversity and communication skills
Revises test information as needed
Serves as a professional role model, working cooperatively with other work units to seek out mutually agreeable solutions to problems
Act as "Industry Luminary on subjects like key True Health philosophies, approaches, methods (GGE testing, Product Development, etc.) as well as current industry "hot topics"
Conducts lab meetings and other meetings associated with the work unit
Presents continuing education, presentations, etc. as appropriate
Ensures that employees are kept informed of policy/procedure changes and current information
Fosters open/trusting work environment
Promotes teamwork and ongoing feedback
Participates in professional organizations/meetings
Develop a plan to execute developmental endeavors
Create and evaluate new procedures and identify equipment for potential use in the laboratory and recommend new procedures and equipment where necessary
Work on strategy and execution with potential business partners of Regulatory Agency (FDA, etc.) related plans
Help create and execute programs (example 510(k)’s) with potential business partners in conjunction with the FDA that fosters the adoption of True Health as infrastructure that benefits both regulatory directions as well as True Health commercial needs to bring more / better available testing to market
Collaborate with CEO on strategy, solution roadmap, go to market, positioning, and other planning activities as necessary to keep ahead of industry needs and initiatives
Work with True Health Product and Sales Managers to resolve scientific trade-off issues and priorities in new test introduction and development
General Supervisor Qualifications--
At least a bachelor's degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution with at least 5 years of training and/or experience in cytotechnology.
Completion of a Cytotechnologist program accredited by the Commission of Accreditation on Allied Health Education Programs (CAAHEP).
Certification by American Society for Clinical Pathologists in Cytotechnology CT(ASCP)
Dual certification as cyto/histo technologists desirable but not required.
State licensure, if applicable.
In-depth knowledge of complex laboratory techniques, laboratory safety and quality assurance needs pertaining to cytology practice in order to support ongoing and future projects.
Experience with drafting and writing and/or modifying SOPs to conform with CLIA/CLSI requirements important.
Ability to communicate well through written and verbal means is required.
Knowledge of CLIA regulations and proficiency testing requirements for cytology laboratories.
Proficient with statistical and computer productivity software (i.e. Word, Excel, etc.) required.
Internal Number: 1
About True Heath Diagnostics
True Health, a privately held company with operations in Frisco, Texas and Richmond, Virginia, is an innovative diagnostics company specializing in advanced clinical laboratory testing which empowers physicians and healthcare providers to more accurately diagnose, manage and prevent the progression of cardiovascular diseases, genetic disorders, diabetes and other metabolic conditions.