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

Location Tokyo, Tokyo, Japan Kita-ku, Ōsaka, Japan Job ID R-104845 Date posted 16/04/2021

【職務内容 Job Description】
Evidence Delivery Lead(EDL) affiliates to Japan Evidence & Observational Research(EOR) . 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
• 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
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

【経験 Experience】

必須 Mandatory

• > 3years Trial Manager experience
• Manage CROs for clinical studies
• Lead protocol development
• Design study outline
• Drive data management activities
• Lead data analysis discussions and result-interpretation discussions
• Execute study reporting activities

歓迎 Nice to have

• Researches using statistics and epidemiology
• Working both in R&D and Medical (>3 years each)
• Experience of real world studies or post lauch studies
• Line management experience
• Clinical Project Leader experience
• Working experience in global organization / teams

【資格 License
必須 Mandatory

• Master degree in a scientific discipline

歓迎 Nice to have

• PhDin a scientific discipline or MD or MPH

【能力 Skill-set】

必須 Mandatory

• Clinical Study Execution
• External Service Provider (i.e. CROs) Management
• Leadership & Communication
• Project Management

歓迎 Nice to have

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

【語学 Languages】

必須 Mandatory

日本語 Japanese:• Read/write scientific documents including economic research in English/Japanese
•Practical English communication skill with AZ speaking level 6/TOEIC 800
• Make a Japanese presentation leading and facilitating the HTA discussions in the global meetings

歓迎 Nice to have

• Demonstrated English communication skills in Global Team or outside Japan


【その他 Others】

必須 Mandatory

• Cross-functional Stakeholder management skill

【キャリアレベル】

E/D

【勤務地】

大阪・東京



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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