What You’ll Do: * Laboratory Oversight & Administrative o Provide effective and efficient scientific direction and oversight for the Bilbao laboratory safety and specialty testing (hematology, chemistry, immunoassays, flow cytometry, molecular…) o Ensure the development, implementation, and compliance of standardized processes for CTI central lab o Ensure that technical staff are qualified, and licensed as required, to perform and supervise all testing and have met training and/or competency requirements o Responsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory tests o Monitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reported o Provide advice to sponsors and clients regarding the significance of laboratory findings o Subject Matter Expert for client interactions and business development activities o Act as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, IVDR,



etc o Oversee and maintain relevant laboratory documentation to ensure inspection readiness o Lead the development and continuous improvement of laboratory quality system and ensure adherence to established processes and plans o Review and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments and nonconforming event reports o Participate in the selection of partner laboratories o Report all concerns of test quality and/or safety to Clinical Director, Integral Laboratory Services * Laboratory Quality Management System (QMS) o 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 o Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of services provi

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