Study Delivery Lead

2週間前

Minato 711 GlaxoSmithKline K.K. Full time

職務の目的および主な業務内容 Job Purpose & Key Responsibilities

職務の目的:

臨床試験の実施計画から実施完了まで、Timeline、Quality、BudgetにAccountabilityを持ち、Local studyの場合はStudy Delivery Lead (SDL) として、またGlobal studyの場合はLocal Delivery Lead (LDL)としてStudy Teamをリードし、臨床試験を推進する。

業務内容:

海外本社の関係部門(特にGlobal SDL)と密接な連携を取り、グローバルな視点で海外チームと日本でのOperation内容を合意した上で、国内関連部門との調整も行い、臨床試験の計画通りの遂行に責任を持つ。

  • 開発戦略立案:日本での開発戦略の策定に参加し、Operationの視点でリスク評価、予定する試験のFeasibility調査及び予算算出を行う
  • 臨床試験の運営:Study実施の具体的方針決定(各種Study levelでの意思決定)、Stakeholder management、被験者登録戦略の計画、CRO Oversight、Study Level問い合わせ対応、モニタリング報告書承認、Budget/Timeline/Study riskの管理

    • 業務全般及び組織運営にかかわる以下の活動を担う。

  • 各プロジェクトのSDL/LDLとの協働し、部内の業務遂行能力(専門的技能・知識等)の向上を担う(組織開発、人財育成)

    • 必要要件 Required Skill, Experience, Etc.

    必要な条件 Basic Qualification

    スキル/知識

  • Leading matrix team
  • Study management skill
  • Stakeholder management and communication skill (社内外/国内外の関係者と良好な関係性を構築し、円滑に業務に取り組める能力)
  • Quality/Process control skill
  • Problem solving skill
  • Decision making skill
  • Management skill(業務・目標管理、リスク管理、人財育成・組織開発)
  • Negotiation skill
  • Agility(環境に合わせて柔軟に適応する能力)
  • 日本での医薬品開発に関連する薬事規制

    • 経験 Experience

  • 臨床試験のOperationならびにStudy managementについて3年以上の経験
  • 臨床試験のOperation業務の一部または全部をCROに外注した試験のStudy managementの経験
  • 様々な部門の代表者から構成されるプロジェクトチームの一員として機能し、ときにそのチーム活動をリードした経験
  • 臨床試験のプロトコールや同意説明文書を作成した経験

    • 学位/資格/語学力 Education/certification/Language

  • 医学、薬学、獣医学、ライフサイエンス分野の学位
  • 海外担当者とコミュニケーションを取り、支障なく業務を展開できる英語力(TOEIC 800点以上相当)

    • 望ましい条件 Preferred Qualification

    スキル Skill

  • 開発戦略の策定に際し、オペレーションの視点で必要な情報を収集・評価できる能力

    • 経験 Experience

  • オンコロジー試験 (特に、第I相試験) のOperationならびにStudy managementの経験

    • 学位/資格/語学力 Education/certification/Language

  • 医学、薬学、獣医学、ライフサイエンス分野の修士、PhDの学位

    • Why GSK?

    Uniting science, technology and talent to get ahead of disease together.

    GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

    Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

    Important notice to Employment businesses/ Agencies

    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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