22 set - Italia
Cti Clinical Trial And Consulting Services
What You'll Do: Laboratory Oversight & Administrative Provide effective and efficient scientific direction and oversight for the Bilbao laboratory safety and specialty testing (hematology, chemistry, immunoassays, flow cytometry, molecular...) Ensure the development, implementation, and compliance of standardized processes for CTI central lab Ensure that technical staff are qualified, and licensed as required, to perform and supervise all testing and have met training and/or competency requirements Responsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory tests Monitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reported Provide advice to sponsors and clients regarding the significance of laboratory findings Subject Matter Expert for client interactions and business development activities Act as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, IVDR,
etc Oversee and maintain relevant laboratory documentation to ensure inspection readiness Lead the development and continuous improvement of laboratory quality system and ensure 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 nonconforming event reports 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 Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of services provided Ensure that the laboratory p
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