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 Testing to support product development in the US for new Hematology and Hemostasis products (reagents and analyzers), working with R&D, Clinical and Regulatory in the US and France to provide appropriate clinical performance information to support device development as well as meeting U.S. regulatory requirements. Provides comprehensive knowledge of instrument operation in support of clinical trials.
Essential Duties & Responsibilities:
Stays current with instrument capabilities and clinical trial regulations in order to provide input to clinical trial designs and execution.
Interacts with groups, such as, but not limited to CLSI, CLIA and CAP in order to ensure Stago is at the forefront of the market's evolution.
Works closely with French counterparts to help conduct and support R&D activities as well as clinical trials in the US in facilitation of new Hematology and Hemostasis product launches.
Participates in the development of study protocols and ensures study designs are appropriate for execution in the lab.
Verify technical conditions prior to the start of a study, ensure instruments are in pristine working order and maintenance of equipment is up to date to ensure successful study conditions.
Utilizing local members of the service operations, create good logistical conditions for clinical studies to include but are not limited to delivery of reagents and/or instrument, specimens, exchange of correspondence, contracts and administrative documents.
Ensures full understanding of the protocol requirements to ensure the study proceeds efficiently in order to meet organizational time lines.
Works closely with the NCRA for all necessary study follow-up in accordance with defined procedure including but not limited to the checklist for site initiation and monitoring visits, etc.
Ensure corrective actions are followed for proper conduct to freeze databases of results in accordance with the studies initial objectives.
Check completeness of records (all forms of media: paper and electronic), ensures centralization and formatting of data from studies, as well as ensuring traceability of data.
Uses knowledge and experience with instrument validation, interference, on-board stability, Limit of Blank, Limit of Detection, 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.
Participates in validation of new equipment as appropriate.
Assists the NCRA’s in the development and maintenance of clinical study binders and utilization of eCRF.
Manages the Laboratory equipment service contracts and documentary elements of clinical trial activities;
Completes 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.
Job 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, experience with instrument validations, correlations and training lab staff on new laboratory instrumentation.
To perform this job successfully, an individual must be 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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
