May develop & implement operating policies & practices to support the strategic plan of the laboratory & the mission, vision & values of the Department/Division/Hospital. Partner with department leadership in the development & implementation of growth strategies, short & long term goals. Manage and guide the daily operations of the laboratory in order to assure overall effectiveness & success. Lead the development & implementation of operating procedures, specifications, validations etc. Implement procedures in laboratory & evaluate their effectiveness. Communicate with, assess & meet the needs of investigators/customers of the laboratory. Ensures services provided are done in a professional & quality manner. May assist in recruitment of new clients & retention of current clients. May collaborate in the investigation of new procedures & products & implement initiatives that are appropriate for providing enhanced customer service & satisfaction. Assist with costing laboratory services provided. Monitor expenditures & prepare capital expenditure requests. May assist in identifying new funding opportunities including establishing lab agreements & contracts with outside clients. Participate on internal & external professional committees & represent the lab on hospital-wide initiatives.
·Human Resource Leadership
Accomplish goals through the leadership of staff. Provide management of all personnel (direct and indirect reports) to ensure achievement of the laboratories' strategic goals and objectives through teamwork, employee achievement and employee development. Manage the recruitment, hiring, development, training, continuing competency and continuing education of personnel. Perform yearly performance evaluations, establish goals, and identify areas of concern. Lead performance management processes to achieve organizational goal and meet the expectations of customers while creating a positive work environment. Work to correct personnel management issues. Develop a proficient understanding of various job functions to ensure efficiency and effectiveness in operations. Ensure compliance with all competency requirements. Work with HR to create and maintain accurate position descriptions and performance evaluation criteria. Delegate responsibilities within the technical staff to ensure that the laboratory is adequately staffed and scheduled.
Ensure quality in all aspects of the laboratory operation, coordinating and collaborating with leadership regarding all testing and reporting issues. Aid in the selection of appropriate test methodologies, verification of procedures and establishing performance characteristics. Responsible for reviewing proficiency testing and following up on outliers. Ensure the procedure manuals are current, available and reviewed annually and that all employees are educated and trained on all revisions. May work with others to research, develop, and implement new tests. May work with principal investigators to design, execute and record laboratory data according to research protocols and modify current procedures through scientific knowledge as appropriate to meet individual study needs. Oversee validation and implementation of new assays. May be required to perform the technical functions of the lab when needed.
Manage the readiness and compliance with all federal, state, and local regulations as appropriate for the assigned laboratory (i.e. CAP/CLIA, GTP/GMP, JCAHO,OSHA). Determine and administer the policies and procedures to assure compliance. Ensure that assigned laboratories maintain a continuous state of preparation for all accreditation surveys, audits, etc and support the operations through, licensures, data output analysis, assay validation, organizing research studies, and QA/QC. Manage audits and ensure that significant findings are addressed and systems put in place to prevent recurring adverse findings. Stay updated on laws and regulations that might affect policies and procedures and update or implement new practices and procedures as needed. Establish and maintain Quality Assurance and Quality Control programs that are effective in identifying problems. Prepare compliances reports and communicate those results to the stakeholder groups annually. Assure that testing systems are functioning properly. Coordinate the interactive operations of the lab to ensure that the needs of regulatory agencies and study sponsors are met and maintained.
·Quality and Safety Management
Ensure quality in all aspects of the laboratory operation including testing and reporting. Manage and oversee the development, implementation and evaluation of safety and quality programs policies and procedures. Ensure that facilities and equipment are compliant with all safety requirements. Work to correct identified safety issue. May act as the Authorized user and monitor for the safe utilization of radioactive materials. Ensure that all chemical inventories and personnel safety training is complete and up to date.
Plan for and manage the financial performance of the assigned laboratory(ies). Work with the Director or other department leadership to develop and monitor laboratory budgets. May develop, evaluate and manage the annual fiscal operating and capital equipment budgets, revenue and expenses. May manage systems to capture all charges in order to maximize reimbursement for rendered services. Seek and facilitate funding opportunities including establishing lab agreements and contracts with outside clients. May direct, coordinate and approve purchasing requisitions, equipment quotes and purchases, leases, cost transfers and vendor/service contracts. May manage coding, pricing and edits to the laboratory's service compendium. Receive, review and prepare technical reports reflecting work volumes and revenue returns, identify trending, and implement appropriate corrective actions if necessary.
Excellent verbal, written and interpersonal communication skills.
Advanced knowledge of the regulatory environment and requirements. May require knowledge of CAP/CLIA and/or GMP.
·Analytics and Judgment
Knowledge and analytical ability sufficient to evaluate data, design and troubleshoot protocols, make judgments and recommendations regarding lab operations, and personnel.
Ability to delegate tasks efficiently among team members.
Strong problem-solving skills.
Demonstrated ability to perform laboratory procedures. Demonstrated experience in writing, approving, and implementing SOPs.