Clinical Laboratory Technologist

Diagnostica Stago-posted 6 months ago
$68,000 - $88,000/Yr
Parsippany, NJ
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Diagnostica Stago, Inc., (DSI) is an industry leader in the science of hemostasis and thrombosis. Stago provides the total commitment of global resources and responsiveness, coupled with cutting edge technology and reliability. DSI is dedicated to continually developing and providing the very best hemostasis products, technical support, and services. Execute Clinical and analytical testing in the US to support product development for new Hematology and Hemostasis products (reagents and analyzers). Works with R D, Clinical and Regulatory in the US and France to verify and validate that new products meet pre-defined specifications and requirements, the intended use, user needs, and requirements in the real-world operational environment as well as U.S. regulatory requirements. Provides comprehensive knowledge of instrument operation in support of clinical validation. Delivers a comprehensive overview of various lab and clinical trials and research projects as needed.

  • Stays current with product and instrument capabilities to advise the organization regarding important scientific developments.
  • Creates and maintains a scientific and technical relationship with opinion leaders.
  • Maintains awareness of new and updated testing standards to provide support to clinical trial designs and execution.
  • Interacts with groups such as CLSI, CLIA, and CAP to ensure Stago is at the forefront of the market's evolution.
  • Works closely with the NCRA to support validation trials in the US for new Hematology and Hemostasis products.
  • Collaborates with French counterparts to conduct and support verification and clinical validation activities in the US.
  • Verifies technical conditions prior to the start of a study and ensures instruments are in pristine working order.
  • Ensures full understanding of protocol requirements to ensure efficient study progression.
  • Participates in the development of study-related materials for verification and validation studies.
  • Assists with the execution of clinical and analytical studies and reports results to external stakeholders.
  • Ensures a field presence during validation study activities and acts as a point of contact for external sites.
  • Conducts necessary training of personnel and ensures maintenance of equipment for successful study conditions.
  • Ensures corrective actions are followed for proper conduct to freeze databases of results.
  • Checks completeness of records and ensures centralization and formatting of data from studies.
  • Uses knowledge and experience with instrument validation to perform various testing methods.
  • Creates good logistical conditions for verification and validation studies.
  • Documents all necessary follow-up to studies in accordance with defined procedures.
  • Enters data into databases or online systems as needed.
  • Issues queries to resolve errors and missing data.
  • Collects agreements, records, labels, forms, and study reports as applicable.
  • Maintains laboratory equipment following maintenance schedules and required quality control.
  • Participates in validation of new equipment as appropriate.
  • Assists in the development and maintenance of clinical study binders and utilization of eCRF.
  • Manages laboratory equipment service contracts and documentary elements of verification and validation studies.
  • Completes necessary documentation and reports for verification/validation studies.
  • Completes necessary clinical trial documentation from the site's perspective.
  • Gives scientific presentations as required.
  • Offers 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 of two years experience as a Technical Support Specialist or Field Support Engineer with Hematology and Coagulation instrumentation required.
  • Minimum five years hospital experience in Hematology and Coagulation preferably experienced with validations, correlations, and training lab staff on new laboratory instrumentation.
  • Experience designing, organizing, and conducting clinical trials is a plus.
  • Demonstrated competency in the review of statistical analysis methods for clinical data is a plus.
  • Experience in IVD product development is a plus.
  • Familiarity with Excel and Windows Office Suite Applications and other company software.
  • Ability to read, analyze and interpret complex documents.
  • Ability to respond effectively to technical inquiries and customer complaints.
  • Ability to write and deliver effective and persuasive technical and non-technical presentations.
  • Ability to work with mathematical concepts such as probability and statistical inference.
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Flexible Spending Account (FSA)
  • 401k
  • Paid Time Off (PTO)
  • Life insurance
  • Disability insurance
  • Comprehensive leave program
  • Bonus plan
  • Automobile plan
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