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新着求人 臨床開発  (MRI-37)
募集職種 外資系製薬企業の Operations,Evidence & Observational Research, Medical
勤務地 東京、大阪
会社概要 非公開
求人要件 Japan EOR Evidence Delivery Leader(EDL) is a project leadership role in delivering * sponsored scientific studies and medical evidence generation to support ** business and value claims, in line with strategy, governance processes and standard operation procedures.
【Business Planning & Control】
• EDL supports Therapeutic Area Medical Affairs(TAMA) Team in organizing the cross functional strategic evidence planning workshops for quality evidence plans as the champion of evidence planning framework
• EDL supports Business Planning Process as EOR window person for each TA team so that the Evidence Generation costs are forecasted as per the agreed evidence plans
• EDL contribute to ensure that Evidence plans/study concepts are scientifically and methodologically feasible to address research questions, feasible to time, cost, quality and capacity
• EDL works with EDOS in planning and controlling to track and manage the progress of Evidence Generation programs as per the agreed business plans (RBU2/LRP/PB)
• EDL ensures the operational/methodological feasibility of the study concepts/plans to initiate
• EDL is responsible to select the best external service providers(ESPs) as per the project requirements and manage the performance throughout the study
• EDL leads delivery of all components of a scientific study to time, quality, budget, project standards, company quality standards, and scientific requirements during the course of the study from SDC development through database lock, analysis, reporting and study closeout activities
• EDL is the cross-functional study team leader ensuring that studies are delivered by leveraging all available best practice, members’ expertise and relevant resources across ** to address research questions
• EDL contributes to uplift RWE capabilities of individuals involved in the Evidence Generation projects
• > 3years Clinical Study Leader experience
o Leading protocol development, study site selection, data management, analysis, result-interpretation and reporting
• Managing CROs for clinical studies
• Researches using statistics and epidemiology• Working both in R&D and Medical (>3 years each)
• Line management experience
• Clinical Project Leader experience• Working experience in global organization / teams
• Master degree in a scientific discipline
• PhD in a scientific discipline or MD or MPH
Clinical Study Delivery
• External Service Provider (i.e. CROs) Management
• Leadership & Communication
• Project Management
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