Study Leader, Clinical Operations

場所: Tokyo, Japan
給与: negotiable
ジョブタイプ: 正社員
この求人に応募する

<仕事内容>

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

<応募資格>

■経験■
<必須>
*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

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

■語学■
<必須 >
*Business
*Native level Japanese

<応募>

こちらのポジションに少しでもご興味がございましたら、Applyボタンをクリックいただき、深澤佳代/KAYO FUKAZAWAまでご連絡ください。

To find out more about Real Staffing, please visit www.apac.realstaffing.com

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

この求人に応募する