外資大手製薬メーカー　Study Manager, Study Manager, Hematology＆Early Development Oncology Clinical Operation, R&D Development Operations Division

資格・要件

＜必須 / Mandatory＞
・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
・Understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g. ICH-GCP/J-GCP, local regulations, study management
・Good experience of clinical development / drug development process in various phases of development and therapy areas
＜歓迎 / Nice to have＞
・Project management certification
・Working experiences in Clinical Development/ Quality Assurance
・PMDA GCP inspection
【経験 / Experience】＜必須 / Mandatory＞
Bachelor’s Degree in Science or related discipline
＜歓迎 / Nice to have＞
Medical or biological sciences or discipline associated with clinical research.
【語学 / Language】＜必須 / Mandatory＞
英語 English: Business English (Achieve common understanding at the context level with customers)

職務内容

Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D.
Clinical Operations is the organizational home for the operational delivery and programme and project management of clinical projects, drug and non-drug.

【その他情報】
契約期間：期間の定めなし
試用期間：6か月
就業時間：9:00～17:15
休憩時間：60分
フレキシブルタイム：あり
時間外労働：あり
休日休暇：
完全週休2日制（休日は土日祝日）
年間有給休暇　初年度12日
年間休日日数121日

■公休日：完全週休2日制(土、日)・祝日・年末年始6日
■休暇：年次有休休暇・慶弔・赴任・リフレッシュ
受動喫煙対策：あり　就業場所　全面禁煙
加入保険：雇用・労災・健康・厚生年金保険
在宅勤務制度：有