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Senior Clinical Project Leader

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Franklin Lakes, United States Katalyst HealthCares & Life Sciences Inc Full time

Responsibilities:

Reviews and interprets medical/scientific data and study results, and technical literature. Monitors trends in specimen management and other related technologies. 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 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, feasibility studies, and due diligence studies related to new technologies and products. Interprets and presents results. Prepares technical reports, abstracts, journal submissions and presents at scientific meetings or within BD. Reviews information and assesses risks related to vendor, material, and manufacturing process changes. Designs clinical studies as needed and interprets and presents results. Provides medical expertise and leadership for Human Factor Engineering (HFE) studies, Health Economics & Outcomes Research (HEOR) studies, post market surveillance and post market studies.

Requirements:

Knowledge of scientific methodologies and clinical laboratory medicine Knowledge of the pre–analytical phase of the total laboratory testing process Knowledge of specimen collection and management Knowledge of clinical trials and ability to craft, review and summarize data from such Excellent interpersonal skills. Proven leadership skills. Proven capability for critical thinking, analytical and problem–solving skills. Ability to work with global teams and to provide clinical leadership within the SM business Ability to integrate medical, scientific, and technical information and effectively communicate these data to the scientific community, customers, as well as throughout the organization. Ability to network/develop relationships with Key Opinion Leaders (KOLs) from the scientific community Strong proficiency in the areas of clinical study design, statistics, technical writing. Proven ability to understand, interpret and explain sophisticated clinical and scientific information. Strong communication skills (verbal, presentation, written) BS in a health–related field, MS or PhD desirable 3+ years of clinical laboratory or related healthcare field experience or clinical research; experience in a medical device/IVD company is a plus. MT(ASCP) or equivalent is desirable