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Location:
Chiyoda, Tokyo, Japan
Job reference: R-053320
Posted date: Jun. 14, 2019
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(職務内容)

Japan EOR Evidence Delivery Leader(EDL) is a project leadership role in delivering AZ sponsored scientific studies and medical evidence generation to support AZ 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)

AstraZeneca Sponsored Studies(AZSS) Delivery
• 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 AstraZeneca to address research questions
• EDL contributes to uplift RWE capabilities of individuals involved in the Evidence Generation projects

※旧MEMポジションとなります。(Medical Evidence Manager,Evidence & Observational Research, Medical

(応募資格)

■経験

≪必須≫

• > 3years Clinical Study Leader experience
o Leading protocol development, study site selection, data management, analysis, result-interpretation and reporting
• Managing CROs for clinical studies

≪歓迎≫

• 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

■資格

≪歓迎≫

• Master degree in a scientific discipline

≪歓迎≫

• PhD  in a scientific discipline or MD or MPH

■能力

≪必須≫

• Clinical Study Delivery
• External Service Provider (i.e. CROs) Management
• Leadership & Communication
• Project Management
≪歓迎≫

• Study Design, Statistics and Epidemiology
• Medical writing & Scientific Publication

■語学

≪必須≫

• Practical English communication skill with AZ speaking level 6/TOEIC 800

≪歓迎≫

• Demonstrated English communication skills in Global Team or outside Japan

■その他

≪必須≫

• Cross-functional Stakeholder management skill

(キャリアレベル)E (D:depending on the experience/competencies)

(勤務地)大阪  or   東京

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【Medical】Evidence Delivery Lead,AZSS Operations,Evidence & Observational Research, Medical
Clinical Development

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