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Principal Clinical Scientist

precision medicine group·LATAM·Mexico·senior
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Position Summary: The Principal Clinical Scientist, Clinical Science Analytics & Insights is responsible for & manages the operational clinical science function from study start up through database lock for assigned projects focused on the scientific & indication specific insights into data collection & data visualization outputs to support scientific, clinical-sense data cleaning as part of Precision’s cross-functional data review team. Serves as the subject matter expert in the application of clinical knowledge, guidelines & standards of care to the review of clinical trial data. Serves & contributes to project teams as the CSAI functional lead delivering within scope, time & cost. Essential functions of the job include but are not limited to: Serve as the functional lead implementing CSAI services per study scope of work (SOW) on assigned project team(s) Serve as a resource for project teams regarding scientific related data capture, review & cleaning. Support & participate in the development & implementation of process flow for integrated, cross[1]functional, data cleaning for interim &/or final study data deliverables between all applicable departments (e.g., data management, medical, safety, vendors, sponsor, etc.) May be responsible to cross-functionally manage the overall data cleaning process internally to support interim &/or final data deliverables (e.g., tier cleaning process/timelines, etc.) Manage Medical Monitor review of subject data. Provide protocol review from a scientific operational perspective. Provide indication-focused, scientific, clinical input & support to Data Management in the development & revision of eCRF specifications, edit checks & completion guidelines &/or other study[1]specific documentation as applicable. Provide indication-focused, scientific, clinical input & support to Data Management in the conduct of EDC UAT supporting the CSAI function as applicable. Collaborate to support cross-functional departmental communication includ