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Clinical Project Leader

Company: CareFusion
Location: Franklin Lakes
Posted on: November 24, 2020

Job Description:

Job Description SummaryReporting to the Associate Director, Medical Affairs Specimen Acquisition (SA) and Emerging Specimen Management (ESM) Business Lines (BL) - Specimen Management, Integrated Diagnostics Solutions- BD Life Sciences, this position has the responsibility to define and implement the safety and efficacy requirements for current and proposed products. The position is also responsible for designing and interpreting results of feasibility, clinical and human factors studies. Additionally, the Clinical Project Leader provides medical, scientific, and technical leadership and perspective to project teams and other functions such as Regulatory and Quality. This position is responsible for identifying, developing and /or evaluating new technologies in scientific disciplines within and outside of the traditional clinical laboratory. The CPL may initiate and coordinate liaisons with internal/external medical, academic, regulatory and industry individuals or groups in support of business needs. The position also generates and communicates clinical and technical information to support, technology development, and product development, sustaining engineering and marketed products. In support of all currently marketed Specimen Management products, the CPL provides technical support in the worldwide markets including customer and associate education, troubleshooting, and competitive assessments. Job Description The Clinical Project Leader will be responsible for the following: - Participates in technology development and product development core teams by sensing and defining key trends and unmet needs in science, technology, medical practice, and health economics. - Participates in sustaining engineering teams by reviewing information and assessing risks related to material and manufacturing process changes. - Provides customer and product knowledge to team. Identifies appropriate clinical and/or other defined testing to address clinical risks for product changes. - Develops safety and efficacy requirements and a clinical test plan to address S & E, Regulatory and Marketing requirements for new and improved products and gains functional approval of such. With the support of the MA team, ensures safety, efficacy and clinical utility of the product, technology and related labeling/promotional material. - Reviews and interprets medical/scientific data and study results, and technical literature. Monitors trends in laboratory medicine. - Communicates findings and interpretations to teams and management. - Interacts with global medical, academic and industry experts to establish strategic direction for innovation, technology and product development projects. - Provides clinical support to products entering or currently on the market including training of customers and BD associates, troubleshooting, data review, interpretation and presentation, post market study design, publications, preparation or review of regulatory communications, and addressing quality issues. - Designs studies, formulates and conducts scientific investigations, and feasibility studies,. Interprets and presents results. - Prepares technical reports, abstracts, journal submissions and may present at scientific meetings or within BD. - Provides clinical consultation for HFE studies, HEOR studies, post market surveillance and post market studies. Education: BS required, preferably in a health-related field, MS desirable - Licenses or Certifications: MT (ASCP) or BSN or equivalent is desirable - Experience: 3-5 years of clinical laboratory experience or clinical research, experience in a medical device/lVD company is a plus. Previous clinical trial experience is desirable Special Skills: - Knowledge of scientific methodologies and clinical laboratory science. - Understanding of clinical studies, study design and study management - Excellent interpersonal and communication skills. Strong communication skills (verbal, presentation, written). Not a supervisory position. Job Group: 3 Primary Work LocationUSA NJ - Franklin Lakes Additional Locations Work Shift

Keywords: CareFusion, New York , Clinical Project Leader, Healthcare , Franklin Lakes, New York

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