Description

Under the direction and mentorship of our Clinical Director, Global Laboratory Services, this position is responsible for providing effective clinical leadership for the development and delivery of global laboratory services and products. This position is responsible for clinical oversight of the North American Central Safety and Cellular Laboratory, assuring that operations are conducted in compliance with applicable regulations.  

Laboratory Oversight & Administrative

• Provide effective and efficient scientific direction and oversight for the CTI North American Central Safety and Cellular Laboratories
• Ensure the development, implementation, and compliance of globalized standardized processes for the CTI Central Safety and Cellular Laboratories
• Ensure that technical staff are qualified to perform all testing and have met training and/or competency requirements
• Ensure all technical staff have current and up to date licensing and credentials
• Delegate the responsibilities of the Laboratory Supervisor, Specialty Laboratory Directors/Supervisors, Quality Control Manager and Testing Personnel to employees who are qualified to perform such duties
• Responsible for designing, validating, and maintaining accurate, precise and clinically useful laboratory tests to meet clients’ needs
• Monitor all work performed in the laboratory to ensure that clinically reliable data is generated and efficiently reported
• Provide advice to sponsors and clients regarding the significance of laboratory findings and ensure that reports of test results include pertinent information required for specific patient/subject interpretation
• Subject Matter Expert for client interactions and business development activities
• Ensure that a supervisor provides onsite supervision of high complexity test performance
• Act as clinical representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, etc
• Oversee and maintain relevant laboratory testing and reporting, laboratory and clinical trial files and other laboratory documentation to ensure inspection readiness at all times
• Lead the development and continuous improvement of laboratory SOPs, and GLPs and provide oversight of laboratory quality & adherence to established processes and plans
• Review and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments, and reagent/control/instrument qualifications, quality audits, deviation approval requests, and nonconforming event reports
• Maintain an effective working relationship with applicable accrediting and regulatory agencies
• Participate in the selection of partner laboratories
• Report all concerns of test quality and/or safety to Clinical Director, Global Laboratory Services

Laboratory Quality Management System (QMS)

• Working with Quality Assurance to support and enforce all aspects of the laboratory’s QMS to ensure conformance to requirements described in the Quality Management System and Clinical Laboratory Practice Standards including management of outcomes and non-conformities, participation in internal quality control system monitoring, and performance in proficiency testing
• Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of Clinical Laboratory Services provided and to identify failures in quality as they occur
• Ensure that the laboratory participates in monitoring and evaluating the quality assurance program by adhering to required regulatory activities, within the context of the
• Quality Management System, regardless of where the testing is performed
• Ensure that the laboratory is enrolled in the appropriate proficiency testing program(s)
• Effectively plan and implement corrective actions to identified non-conformances
• Perform and document monthly quality audits of all testing equipment to ensure optimal accuracy and performance
• Laboratory Information Management System (LIMS)Work with the IT Manager and Lab Leadership Team to optimize LIMS performance
• Personnel Management
• Ensure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills
• Provide continuing education to laboratory technical staff that is relevant to laboratory medicine
• Ensure that an approved procedure manual is available to all personnel
• Environment, Health & Safety
• Promote a safe laboratory environment for personnel and the public
   

Requirements

• Relevant clinical and technology expertise
• Strong organizational and problem-solving skills and the ability to set priorities
• Strong computer skills, including laboratory data acquisition technology
• Ability to read, analyze and interpret complex documents
• Ability to delegate, set expectations and monitor activities
• Leadership, ability to engage and manage a local team
• A Medical Degree (MD) or Doctoral degree (PhD) in clinical laboratory science, chemical, physical, or biological science that would meet the requirements to be a High Complexity Laboratory Director under CLIA/CAP
• At least 5 years’ experience as a Clinical Laboratory leader with previous experience across multiple clinical disciplines
• Certification: Must meet the license requirements of the position set by the State(s), Must possess training and/or experience, obtained within the previous six years, in generally accepted and currently used methods and techniques in one or more categories listed below and must meet one of the following requirements:
• Be a physician who is currently certified by the American Board of Pathology in: Clinical Pathology; or an area of special competence relevant to the certificate of qualification sought; or be a physician or hold an earned doctoral degree from an accredited institution in an applicable field including: chemical, biological, clinical, or medical laboratory science and post-doctoral training in Clinical Laboratory Medicine
• Is currently certified by any of the following: The American Board of Bioanalysis, The American Board of Medical Microbiology, The American Board of Clinical Chemistry, The American Board of Forensic Toxicology, The American Board of Medical Laboratory Immunology, or The American Board of Internal Medicine in Hematology, The American board of Medical Genetics and Genomics
• After receiving a Doctor of Medicine, Doctor of Osteopathy or earned doctoral degree, has documented at least five years of training and/or experience in an acceptable clinical laboratory. The training and/or experience must have been in methods and techniques currently in use in the certificate category or categories sought and in general laboratory management, or an equivalent combination of training and/or experience