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| Clinical Science Manager IN Open (J#45154) Title: Clinical Science Manager Company: Roche GB The Position The Clinical Science Manager facilitates and develops relationships with medical and scientific thought leaders in the community to ensure competent knowledge of indication areas and clinical utility of Roche and other competitive related products. Responsibilities include comprehensive medical and technical guidance in the assigned indication areas and provides US competent support to LCT, CDT, DAST, Regulatory Affairs, IBL and other global team leaders as the US SME (systems matter expert) with full knowledge of US diagnostic product usage in different indication areas; ensuring that the necessary medical/diagnostic competencies of homogenous assays are thoroughly reviewed for product planning and execution in the R&D and Clinical Operations business segments; timeline and budget planning and execution; ensuring the study types planned meet US/EU requirements for CE and FDA approvals; assigning and ensuring delivery of specific tasks to/from other members of the Clinical Operations study team including keeping study monitors updated on all relevant clinical trials strategies, strategy changes and all relevant study activities and/or changes; providing oversight to outside support including CROs, consultants and/or medical advisors; and ensuring that the data and reports necessary for the characterization, registration and marketing of products have been agreed upon and are available and documented (IVD, FDA) in a timely manner and that the results of the studies are presented in workshops, publications and other printed media according to the requirements of the market and customers. More... | |||
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