Instrumentation and Validation Expert

6 days ago

Budd Lake, New Jersey, United States Diagnostica Stago, Inc. Full time
Job Summary

We are seeking a highly skilled Laboratory Technologist to join our team at Diagnostica Stago, Inc. as a Clinical Testing Specialist - Hematology and Hemostasis. This role will involve executing clinical testing to support product development in the US for new Hematology and Hemostasis products.

Key Responsibilities
  • Stay current with instrument capabilities and clinical trial regulations to provide input to clinical trial designs and execution.
  • Interact with industry organizations, such as CLSI, CLIA, and CAP, to ensure 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 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, and ensure corrective actions are followed for proper conduct.
  • 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.
Requirements
  • 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.

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