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Japan Study Lead

Rare Disease Leading Company

職種臨床開発
給与 800 - 1600 万円
日付2018-01-19
業種バイオテクノロジー
勤務地東京
求人番号Job-00041071

会社概要:

A Fortune 500 company in the pharmaceutical industry, this is a leading company in the research and development of technologies in the treatment of diseases and major health issues across the world. Since established, they have rapidly grown in to a top-tier provider of pharmaceutic technologies, and their mission is to continue to provide meaningful and innovative therapies to patients worldwide.

業務内容:

Job Overview:
Japan Study Lead (JSL) partners with Clinical Operations Lead, Clinical Project Manager of partner CRO and other functions (both of global and local) to develop incountry operationally feasible execution plan and manage in-country clinical operations. Leverage phase and in-country operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP)/Japan CDP and program level strategy. Independently oversees and takes leadership for one or more clinical studies by establishing the in-country operational strategy and securing excellence in execution through the CRO partner.

Principal Accountabilities:

  • For assigned studies, Conducts study feasibility assessment including KOL engagement by working collaboratively with clinical development MD.
  • For assigned studies, Develops and maintains country operational strategy and input it into global operational strategy and J-CDP.
  • For assigned studies, Acts as a member of global Study Management Team (SMT) and ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issue for Japan.
  • For assigned studies, Oversights the tactical execution of the operational strategy for Japan by the partner CRO and effectively leads the study through oversight the CRO.
  • For assigned studies, Manage study quality thorough Sponsor Oversight Visit (SOV) or GCP document check. Support GCP inspection including preparing PMDA pre-submission documents
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    応募条件:

    Minimum Education Requirements:
    Science background and education (Bachelor’s Degree or equivalent)
     
    Minimum Experience Requirements:
    Total 7+ year experience in clinical development field and 3+ year experience of managing clinical trial activities, especially leading clinical study in clinical operations. Need global study experience. CRO oversight experience is preferable
     


    BRS Consultant

    Koto Ikeda

    Pharma

    Tel: 03-6370-8015

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