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
  • ※職務内容および勤務地の変更範囲は会社の定めるところとする。

    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.


    • Study Delivery Lead

      1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 · ※職務内容および勤務地の変更範囲は会社の定めるところとする。 · 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 ...


    • 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 ...


    • Minato Universal Beijing Resort IT

      私たちがDigital Transformationで目指すもの · 世界中からますます注目を集め、さらなる発展が予想される大阪ベイエリア。 · 国内外から多くのゲストがUSJ、そして大阪というDestinationを訪れられます。 · その中で、ゲストの体験価値をより豊かなものにするため、パーク来場前・来場中・来場後とシームレスなデジタル体験を提供すべく、ダイナミックかつ革新的なDXを目指しています。 · 米国本社とのプロジェクト協働でもあり、困難なチャレンジも少なくないですが、他では味わえない貴重な体験・キャリアを得られる機会です。 · 私たちと一 ...


    • Minato AbbVie Full time

      求人内容 · Purpose: The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries. · Note: Specialists will report into their local country COM but hav ...


    • Minato 711 GlaxoSmithKline K.K. Full time

      Responsibility: · Co-develop global medical strategy to cater local unmet medical needs · Support local EE network development and transfer of relationship ownership to Vaccine and Infectious Disease team · Deep capabilities of MSLs to have a meaningful exchange with their EEs · ...


    • Minato Universal Beijing Resort IT

      What we are aiming for in Digital Transformation · The Osaka Bay Area is attracting more and more attention from all over the world, and further development is expected. · Many guests from Japan and abroad visit Osaka and Universal Studios Japan. · Under these circumstances, in ...


    • Minato JP007 Oliver Wyman Group Kk Full time

      Description: · Senior Analyst · Antitrust · Tokyo · NERA Economic Consulting is a global firm of experts dedicated to applying economics, finance and quantitative principles to complex business and legal challenges. For over 60 years, NERA's economists have been creating strat ...


    • Minato JP007 Oliver Wyman Group Kk Full time

      Description: · NERA Economic Consulting is a global firm of experts dedicated to applying economics, finance and quantitative principles to complex business and legal challenges. For over 60 years, NERA's economists have been creating strategies, studies, reports, expert testimo ...

    • L&D Partner

      1週間前


      Minato AIG Full time

      職務目的(Job Purpose) · L&D Business Partnerは、ビジネス部門、個人の目標達成を促進するためのパフォーマンスのギャップ分析、学習ニーズの診断、適切な能力開発ソリューションの特定およびその設計、促進において、ビジネスリーダーと協力して、人材育成をする。 · 組織のパフォーマンスを最大化させるために、計画的な変革を通じて組織開発をする。 · Global L&Dと連携しながら、グローバルプログラムの日本への導入をリードする。 · 職責(Job Responsibilities) · ビジネスリーダー(Stakeholders ...


    • Minato JP001 Marsh Japan, Inc Full time

      Description: · Marsh is seeking candidates for the following position based in the Tokyo, Japan office. · Client Executive/法人営業職[Global Risk Managment Team - Agent]- マーシュ/Marsh - Tokyo, Japan · What can you expect? · マーシュジャパンのGlobal Risk Management Team - Agent(略称GRMA)は、日系多国籍企 ...

    • VEO Expert

      1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 · VEO Expertは、担当品目のValue Evidence Plan (VEP)とIntegrated Evidence Plan (IEP)の内容の企画・策定 · およびその計画の実行に責任を持ちます。Evidence NeedsおよびGapを評価し、製品価値を高めるための最も · 適切な試験やデータベース研究の計画を組織横断チームにて企画・立案・提案し、その実行とEvidenceの公表 · までの広い責任と職務をリードしていきます。 · ...


    • Minato The Walt Disney Company (APAC) Regular

      Job Summary: · • Lead for Disney+ Brand Marketing · • Corporate Brand Management · • Brand/Franchise Marketing (Mickey & Friends/Disney Princess/Frozen/Marvel/Star Wars) · Job Responsibilities: · • Lead for Disney+ Brand Marketing · • Formulate communication strategies for the ...


    • Minato Cisco

      What You'll Do · As a CX Principal, you will play a pivotal role in driving the successful adoption Cisco technologies and services within our customer organizations, leading to value realization and business growth. You will be the primary CX point-of-contact for customers, tak ...


    • Minato Cisco

      What You'll Do · As a Customer Experience Manager, you will play a pivotal role in driving the successful adoption and utilization of Cisco technologies and services within our customer organizations leading to value realization and growth of our business. You're the primary CX ...


    • 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 · The Japan Medicine Development Lead (J-MDL) is accountable for a medicine development in Japan to ensure delivery differentiated medicines of value for patients, stakeholders and markets in Japan. The J-MDL serves as t ...


    • Minato Disney Experiences Permanent

      Résumé du poste: · Job Summary: · We are seeking an experienced Creative Operations Associate Manager for Asia Pacific, to manage operational works across the creative outputs of the APAC Creative team. This role is based in Japan and will have a focus to support the Japan base ...

    • Service Manager

      2日前


      Minato Entegris Full time

      Job Description: · Job Overview: · This technical leadership will have tremendous visibility within the company, leading Japan and Korea service to solve our customers' most challenging problems and gather new potential opportunities. This role provides service energy for Japan ...


    • Minato Cisco

      What You'll Do · As a Customer Experience Manager, you will play a pivotal role in driving the successful adoption and utilization of Cisco technologies and services within our customer organizations leading to value realization and growth of our business. You're the primary CX ...

    • Japan Lead

      2日前


      Minato 711 GlaxoSmithKline K.K. Full time

      Job Purpose · Background: · Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. · To achieve our ambitious goals, we will accelerate the transformation by merging 2 functions ...

    • Financial Analyst I

      1週間前


      Minato American Express

      You Lead the Way. We've Got Your Back. · With the right backing, people and businesses have the power to progress in incredible ways. When you join Team Amex, you become part of a global and diverse community of colleagues with an unwavering commitment to back our customers, com ...

    • MSL(Oncology)

      2日前


      Minato 711 GlaxoSmithKline K.K. Full time

      Job purpose · Medical Science Liaison (MSL) is a field-based role in the new Medical and Development organization, reporting to MSL Head. · In order to build a trust with External Experts (EE) and scientific community through, MSL needs to play a role as external facing function ...