Laboratory Technologist

We are seeking a highly skilled Laboratory Technologist to join our team at Diagnostica Stago. The successful candidate will be responsible for executing clinical testing to support product development in the US for new Hematology and Hemostasis products.

• Stay current with instrument capabilities and clinical trial regulations to provide input to clinical trial designs and execution.
• Interact with organizations such as CLSI, CLIA, and CAP to ensure Diagnostica Stago is at the forefront of market evolution.
• Work closely with French counterparts to conduct and support R&D activities and clinical trials in the US for new product launches.
• Participate in the development of study protocols and ensure study designs are appropriate for execution in the lab.
• Verify technical conditions prior to study start, ensure instruments are in pristine working order, and maintain equipment to ensure successful study conditions.
• Utilize local service operations to create good logistical conditions for clinical studies, including delivery of reagents and/or instruments, specimens, exchange of correspondence, contracts, and administrative documents.
• Ensure full understanding of protocol requirements to ensure study proceeds efficiently and meets organizational timelines.
• Work closely with the NCRA for all necessary study follow-up, including site initiation and monitoring visits.
• Ensure corrective actions are followed for proper conduct to freeze databases of results in accordance with study initial objectives.
• Check completeness of records, ensure centralization and formatting of data from studies, and ensure traceability of data.
• Use knowledge and experience with instrument validation, interference, on-board stability, Limit of Blank, Limit of Detection, and Limit of Quantification to perform Linearity and Method Comparison testing.
• Maintain laboratory equipment following daily, weekly, and monthly maintenance schedules, as well as required quality control for all laboratory analyzers.
• Participate in validation of new equipment as appropriate.
• Assist the NCRA in the development and maintenance of clinical study binders and utilization of eCRF.
• Manage laboratory equipment service contracts and documentary elements of clinical trial activities.
• Complete necessary clinical trial documentation from the site's perspective, in preparation of study start-up.
• Give scientific presentations as required.
• Offer support on new product launches as needed.

• B.S. Medical Technology/Clinical Laboratory Science or equivalent from an accredited four-year college or university required.
• MT(ASCP) Certification or equivalent preferred.
• Minimum five years experience in Hematology and Coagulation, preferably with instrument validations, correlations, and training lab staff on new laboratory instrumentation.
• Proficient with Excel and Windows Office Suite Applications.
• Ability to read, analyze, and interpret complex documents; respond effectively to technical inquiries.
• Ability to write and deliver effective and persuasive technical and non-technical presentations to senior management, sales, and service staffs, and customer representatives as required.
• Ability to work with mathematical concepts such as probability and statistical inference.
• Travel may be required for this position up to 10%, must be able to travel internationally.