Study Leader, Clinical Operations

場所: Tokyo, Japan
給与: negotiable
ジョブタイプ: 正社員


To deliver clinical studies in Japan

*Manage a cross functional team of clinical experts to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality including documentations.

*Provide input into study start up activities (e.g. study feasibility, study specifications, vendor/partner contracts, authoring of clinical study protocols and budgeting including authorization and governance of payment).

*Oversee the delivery to plan of studies performed through external partners (such as Alliance partners, CROs, vendors and Academic Research Organizations) and to monitor progress, identify and solve operational issues.

*Lead and manage all activities related to site management and monitoring including the following with agreed timelines, agreed budget and company standard quality.

*Plan and deliver a site selection strategy

* Patient recruitment strategy including SMO managements

* Lead and manage CRAs including CRO CRAs to deliver clinical study data


*University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
*At least 5 years' experience from within the pharmaceutical industry or similar organization or academic experience.
*Extensive knowledge of clinical operations, project management tools and processes
*Good experience of clinical development / drug development process in various phases of development and therapy areas

<必須 >
*Developing partnering
*Financial/Fiscal Awareness and Supplier/Partnership Management

<必須 >
*Native level Japanese


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