Ideal candidates can be located in the Continental United States.
Essential Duties & Responsibilities:
- Designs and writes detailed training materials.
- Design and writes investigational clinical trial research protocols detailing study procedures, hypotheses, and aims.
- Assesses design constraints (cost, complexity/risk and timeframe) at an early stage of the project for presentation to management.
- 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.
- Collaborates on development of study protocols, data collection tools, lab manuals, case reports, and databases with French counterparts to help conduct and support clinical trials in the US regarding support new Hematology and Hemostasis products and parts
- Drafts the Clinical Trial Management Design to include study sites led by motivated, innovative and dynamic opinion leaders in the fields of Hematology and Hemostasis.
- Leads field evaluations for potential study sites in collaboration with the NCRA
- Communicate and train NCRA’s on the protocol and supports the NCRA with the execution of the study to all external stakeholders (biologists, clinicians, lab techs) for evaluations of new and existing products.
- In conjunction with the Manager, following clearance, present study outcomes to an internal multidisciplinary team.
- Performs validation checks to ensure completeness and consistency of data
- Uses professional knowledge of statistics/biostatistics to collect, analyze, scrub, summarize, and present data, as well as to draw conclusions
- Creates final reports on findings and study results.
- Keeps current with FDA as well as CLSI regulations that impact coagulation and hematology and clinical trial conduct overall
- Responsible for the development of study related documents such as study protocol, SIV presentation, RDO, eCRF, DCF, Final Report (as applicable) and all related materials needed to conduct clinical studies. Also responsible for the validation of eCRF’s and DCF’s for study specific data capture.
- Assist in the development and monitoring of the study budget and study cadence.
- Responsible for review and statistical analysis of the data including drafting of the statistical report and final study report.
- Support on boarding of investigational sites in collaboration with the NCRA’s, for the conduct of clinical trials.
- In collaboration with the NCRA, manage the contractual and documentary elements of clinical trial activities.
- Give Scientific Presentations as required
- Offer support on new product launches as needed.
- Responsible for corroboratively working with Marketing to formulate external communication of study results in the form of publications, posters, etc.
Education and/or Experience
- B.S. in R&D Engineering / Biomedical Engineering or Medical Technology/Clinical Laboratory Science or equivalent from an accredited four-year college or university required.
- MT(ASCP) Certification or equivalent required
- Minimum five years hospital experience in Hematology and Coagulation preferably experienced with validations, correlations and training lab staff on new laboratory instrumentation.
- Experience in project management, designing, organizing, and conducting clinical trials.
- Demonstrated competency in the statistical review and analysis of clinical data.
- Experience in IVD product development is preferred.
- Applications, Minitab, Analyze-it or other statistical software and other company software.
Up to 40% US travel required during clinical trial conduct.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
