What You'll Do: No deje pasar esta ocasión, inscríbase rápidamente si su experiencia y habilidades coinciden con lo que se indica en la siguiente descripción. * 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 Practi

📌 Clinical Director, Laboratory Services (Bilbao)
🏢 Cti Clinical Trial And Consulting Services
📍 Bilbao