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Job Description

Company Overview
Global Pharmaceutical Company
製薬会社

Job Description
・Clinical Scientist for Phase I/II studies including multi-country / multi-center trials.
・Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) to ensure all trial deliverables are met. Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, TA Heads and project team members.
・Lead all aspects of study planning and in collaboration with outsourcing/feasibility personnel, CTT members, local country office representatives and CRAs. Identify sites and manage study set-up, including responsibility for organizing and chairing investigator meetings, or site initiation meetings.
・Interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations and maintaining awareness of issues raised.

・第I相試験・Proof of Concept (PoC) 試験のリーダーとして国内及び海外のチームメンバーをリードし臨床試験の計画・実施・報告を責任を持って遂行する
・試験実施計画書,同意説明文書の作成 (英語版及び日本語版)
・治験計画届に対する照会事項回答の作成
・臨床試験にかかわる文書 (統計解析計画書など),システム (EDC,データベースなど) の文書作成・業務進捗管理

Requirements
・PhD level scientist with life sciences background(Preferred)
・PharmD; BSc or MSc in life sciences(minimum/desirable)
・Fluent Japanese and Business-level oral and written English
・Approximately >5 years’ experience in clinical trials / drug development.

・臨床試験の立案・実施または臨床開発の実務経験(5年以上)
  試験のリーダー経験があることが望ましい
  グローバル試験のマネジメント経験があることが望ましい
・プロジェクトマネジメントスキル Intermediate
・理科学系学部の学位 修士号以上