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Summary: Develop, conduct and support clinical trials in the US for new Hematology and Hemostasis products (reagents and analyzers), working with regulatory and clinical staff in the US and France along with Research & Development to provide appropriate clinical performance information as required to meet U.S. regulatory requirements. Delivers a comprehensive overview of scientific capability of clinical trial sites as needed.

Essential Duties & Responsibilities:

• Stays current with product capabilities and industry in order to advise the organization regarding important scientific developments as well as creating and maintaining a scientific and technical relationship with opinion leaders.
• 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 clinical trials in the US in support of new Hematology and Hemostasis products and parts.
• Participates in the Clinical Trial Management Design to include study sites led by motivated, innovative and dynamic opinion leaders in the fields of Hematology and Hemostasis.
• Participates in the development of study protocol and all related materials needed to conduct field evaluations and may periodically be required to lead these efforts.
• Communicate and train stakeholders on the protocol and assist with the execution of the study to all external stakeholders (biologists, clinicians, ARC, lab techs) to support new and existing products.
• Ensures a field presence to oversee activities with follow up on its evolution and to be point of contact for the final version to sites participating in the clinical trial.
• Verify the technical conditions prior to the start of study, conduct necessary training of personnel and ensure maintenance of equipment is up to date for successful study conditions.
• Utilizing local members of the service operations, create good logistical conditions for clinical trial studies to include but are not limited to delivery of reagents and/or instrument, exchange of correspondence, contracts and administrative documents.
• Ensures successful protocol implementation and monitors the clinical trial sites to ensure the study proceeds efficiently in order to meet organizational time lines.
• Documents all necessary follow-up to study in accordance with defined procedure including but not limited to monitoring plan, checklist of setting up visits, monitoring, 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 and notebooks (all forms of media: Paper and Electronic), ensures centralization and formatting of data from studies, as well as ensuring traceability of data
• Participate in analysis and interpretation of results in multidisciplinary teamwork with internal colleagues, development based counterparts and clinical investigators.
• Is required to provide on-site support for clinical trial preparation, execution, and monitoring.
• Key interface between SNA (Stago North America) and DGA (Diagnostica Stago) for all clinical studies conducted in the US.
• Keeps current with FDA on proper document submission for projects as well as CLSI regulations that impact coagulation and hematology.
• Participates in the selection and qualification of investigators and sites used to conduct clinical trials.
• Assist in the development and maintenance of clinical study binders and utilization of eCRF.
• Manage the contractual and documentary elements of clinical trial activities; Study site set-up, training of trial staff, monitor progress for the correct application of the study protocol).
• Assist or author directly the study protocols, monitoring plans, eCRFs, and final clinical study reports and may periodically be required to lead these efforts.
• Give Scientific Presentations as required.
• Offer support on new product launches as needed.

Education & Requirements:

• B.S. Medical Technology or equivalent from an accredited four-year college or university required;
• MT(ASCP) Certification or equivalent required;
• Minimum of five years hospital experience in Hematology and Coagulation preferably experienced with validations, correlations and training lab staff on laboratory instrumentation.
• Experience designing, organizing, 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.
• Current driver's license is mandatory.
• Up to 80% travel required during execution of studies.

Skills:

• To perform this job successfully, an individual should be familiar with Excel and Windows Office Suite Applications and other company software.

This job requires the individual to be fully vaccinated against COVID-19, absent a legally required accommodation, as determined by customer requirements.

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.