外資製薬メーカー/PROTOCOL MANAGER, Medical Data Operations (MDO)の求人【バイオ転職ナビ】


PROTOCOL MANAGER, Medical Data Operations (MDO) 急募求人  /  外資製薬メーカー

職種 PROTOCOL MANAGER, Medical Data Operations (MDO)
社名 外資製薬メーカー
業務内容 ・A World Wide Medical Data Operations Protocol Manager (PM) will provide end-to-end management of Non-Regulatory Data Generation (NRDG) research.
・The position will focus on Japan-Specific projects
・The PM will provide operational expertise to support programs across brands and will focus on studies including late stage interventional research, Investigator Sponsored Research (ISR), Expanded Patient Access (EPA) & other study types. .Protocol managers act as a matrix leader for the Study Management Team and are accountable for the timely execution of NRDG.
・Manages complex and varied study types across a matrix organization.
・Uses clinical trial management systems to track metrics, timelines, and other data to assure Protocol and/or Program quality, timelines and budget are managed according to expectations.
・Facilitates identification and prompt escalation of project risks and issues along with mitigation / resolution strategies to appropriate stakeholders and/or functional management, to expedite resolution.
・Proactively analyzes and drives efficient problem solving within team’s control.
・Applies critical thinking to manage complex issues.
・Effectively leads team in collating information for operational reviews, highlighting issues and risks, developing mitigation and resolution strategies, and promptly responding to action items.
・Manages clinical components of vendor selection and acts as a central point of contact for communication between the team and the external partners (e.g., CRO, networks, alliance partners etc.).
・Allows vendors autonomy in managing their assignments, while holding them accountable for deliverables. Ensures that tasks assigned to vendors are not duplicated by internal protocol/program team members.
・Builds strong relationships and encourages collaboration with team members and internal and external stakeholders across organizational, functional, and geographic boundaries to achieve project and/or program deliverables.
・Creates synergy with stakeholders and develops strong alliances with the Medical Monitor/Study Director, Operations Lead, and other team members. Effectively leverages network of internal and external contacts.
求める経験 ・Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process.
・Strong understanding of GCPs, ICH and regulatory guidelines as they apply to protocol management and program strategy.
・Understands the influences of safety and efficacy profiles, labeling, legislation and marketing on the life cycle of a compound.
・Minimum education BA/BS.
Prefer individual with:
・strong science background
・minimum of 5 years of demonstrated complex trial management experience in the pharmaceutical or CRO industry
・excellent English speaking & writing skills

語学力 英語力:中級
年収 800万円 - 1200万円
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


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Site Engineering Head

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