外資製薬メーカー/Study Manager, Clinical Operations (炎症・免疫/血液癌)の求人【バイオ転職ナビ】


Study Manager, Clinical Operations (炎症・免疫/血液癌) 急募求人  /  外資製薬メーカー

職種 Study Manager, Clinical Operations (炎症・免疫/血液癌)
社名 外資製薬メーカー
業務内容 <Summary/Scope>
The Study Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, JGCP, Regulatory Authorities’regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include operational direction of one or more cross-functional Japan study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO).
Study manager has full responsibilities for studies led by the Japan Study Team. Responsibilities in the global study is complied with Affiliate Involvement Model (AIM), Job aid and direction given by Global Clinical Trial Manager (CTM).
Responsibilities involve a combination of execution and oversight-dependent on the sourcing model - to ensure deliverables and may include, but are not limited to, the following:
-Financial Planning and Management
・Strong understanding of the cost drivers, attuned to principles of cost disciplined science and are able to proactively manage the study budget
・Takes ownership and accountability for the development/management/reconciliation of overall study budget(s)
・Development/management of vendor scope of work (SOW) per contract, quality, and budget
・Review/approval of vendor invoices and management of accruals and SOW changes
・Review/approval of site invoices and management of site budget
-Project Management
・Drive study execution
・Oversight of clinical monitoring quality and adherence to established processes and plans
・Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders using data and strong inter-personal influencing skills to make robust data driven decisions
・Proactive identification of potential risks and development/implementation of actions to avoid or mitigate and able to make the appropriate trade-offs of balancing risks with study deliverables and costs.
・Maintenance/updating of data as appropriate in project management tools including CTMS
・Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation
-Study Planning and Conduct
・Facilitation of site feasibility/selection processes with use of robust data
・Operational and strategic input into study documents such
求める経験 <Skills/Knowledge Required>
・Clinical trial project management skills
・Financial budgeting and forecasting skills
・Leadership / influence management skills
・In depth knowledge of ICH/GCP, JGCP, regulatory guidelines/directives, and drug development and clinical research processes
・Ability to effectively lead a cross-functional team in a matrix environment
・Time management skills ・ ability to effectively multi-task and prioritize
・Proven problem solving and decision making skills
・Demonstrated success in using oral and written communication skills to influence, inform, or guide others
・Disease / therapeutic knowledge
・Solid computer skills ・ requirement of MS applications including (but not limited to),Word, Excel
・Study Tools including electronic system skills ・ CTMS / EDC
<Key Leadership Competencies>
・Creates realistic plans that clearly define goals, milestones, responsibilities and results
・Maintains focus on strategic objectives while accomplishing operational goals
・Places a priority on getting results with an emphasis on high quality outcomes
・Holds self and others accountable for accomplishing goals
・Makes timely, data-driven decisions
・Develops and maintains effective working relationships with people across cultures
・Encourages collaboration across teams, functions, and geographies
・Ensures that conflict is handled constructively so that performance is not impacted
・Displays a willingness to challenge the status quo and take risks
・Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute
・Maintains optimism and composure in times of change, uncertainty, or stress
-Organizational Impact
・Contributes to Japan R&D objectives
・Moderate impact on study team
-Discretion/Latitude (Level of Independence)
・Requires moderate oversight
・Sets priorities with guidance
・Minimum 2 years experience of the pharmaceutical/medical field
血液癌の場合「Acute leukemia 急性白血病, or high risk MDS治験経験者」を希望
語学力 英語力:中級
年収 800万円 - 1100万円
雇用形態 正社員(期間の定めなし)










  • 人気企業(大手企業・優良企業)や人気業種
  • IPO要員や新規事業立ち上げなど重要度なポジション



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当社の全製品の安全管理、市販後調査の企画から実施までをご担当いただきます。 未経験の職務があっても、社内の協力体制のもとで経験を積んでいただける環境です。 ■医薬安全情報室(募集:1名) ・国内外から収集される安全性情報の収集、評価 ・安全確保措置の立案 ・RMP(リスクマネジメントプラン)の立案、作成 ・安全性症例定期報告の作成 ・添付文書の作成、改訂 ・安全性情報データベースへの入力 など ■市販後調査室(募集:1名) ・市販後調査の企画、立案、実施 ・再審査申請の企画、進捗管理 ・市販後調査結果の評価 ・CRO委託管理(データマネジメント、統計解析等) など


【プロトコール作成から施設選定、海外での治験説明会参加、試験実施、当局査察対応まで含む幅広い臨床開発業務を担当します】 ■想定している担当領域は糖尿病の第三フェーズです。今後も成長ホルモンや肥満適応拡大を目指す薬剤など複数の開発計画があります。 ■モニター業務は、グローバルポリシーとして、CROはほとんど使わず、自社のCRAが行っています。迅速で的確な対応はドクターからの信頼も厚く、試験のスムーズな実施のみならず薬剤の信頼にもつながっています。 ■ご経験によりトライアルマネージャーなどに進む方もいます。 ※シニアCRAの方には、経験を活かした専門性の高いモニタリング活動およびCRAの指導も期待します。 【今後の開発計画】 開発中 第Ⅲ相臨床試験  ・糖尿病(1型および2型)  ・血友病A患者の出血治療及び出血予防  ・血友病B患者の出血治療及び出血予防  ・ヌーナン症候群における低身長  ・成人に対する成長ホルモン補充療法 ※国際共同治験においては、モニターミーティング、治験説明会、治験結果報告会等を海外で実施することも多く、海外出張の可能性がございます。

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