Study Leader, Clinical Operations
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
*Financial/Fiscal Awareness and Supplier/Partnership Management
*Native level Japanese
Real Staffingについてもっと詳しく知りたい方はこちらへ→ www.apac.realstaffing.com/ja