ジャパン スタディ マネジャー/Japan Study Manager

3週間前

Tokyo Pfizer

職務内容

スタディ・マネジャーは、日本国内において治験の管理・監督を担い、CROや治験実施医療機関と連携しながら、治験参加者の安全と福祉、治験の品質を確保し、治験の計画通りの実施をリードします。グローバル・ローカル双方と連携し、課題解決や進捗管理も担当します。

Job Summary & Responsibilities

  • Responsible for in country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards.
  • Provides quality oversight to the CRO and of the CRO deliverables related to study execution. Leads and coordinates the execution of a clinical trial from study start-up through database release and inspection readiness to ensure timely delivery of quality study data. Provides leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans
  • Act as core member of the Study Team and will represent the CRO on matters of study execution.
  • Accountable for managing investigator site relationships to ensure effective delivery of clinical trials (e.g., study start up, enrollment, database release), to safeguard the quality of investigator sites (e.g., site health, patient safety) and to maintain investigator and study coordinator engagement and satisfaction.
  • Acts as local expert for the assigned clinical trials and brings that expertise to support the investigator site, which includes the investigator, study coordinator, pharmacist etc, and to oversee and support the site monitor in the conduct of clinical trials. This role is responsible for the resolution of protocol-related issues at the local level.
  • Ensure timely communication with bidirectionally between global and local study team.

Qualifications / Skills
Training and Education Preferred:

  • Study management and site management experience
  • Working knowledge of GCPs, monitoring, clinical and regulatory operations
  • BS – minimum of 4 years relevant experience
  • MS/PhD – minimum of 2 years relevant experience

Language:

  • Excellent writing and communication skills in both Japanese and English is required.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

  • ジャパン スタディ マネジャー/Japan Study Manager

    3週間前

    Tokyo Pfizer

    +This role involves managing clinical trials in Japan including study start-up through database release and inspection readiness to ensure timely delivery of quality study data. · +

  • ジャパン スタディ マネジャー/Japan Study Manager

    1ヶ月前

    Tokyo Pfizer Full time￥4,500,000 - ￥9,000,000 per year

    Manage study sites in Japan, ensuring patient safety and quality execution of clinical trials. Collaborate with CROs and Pfizer standards. · ...

  • ジャパン スタディ マネジャー/Japan Study Manager

    1ヶ月前

    Tokyo Pfizer ￥600,000 - ￥1,800,000 per year

    Responsible for in country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards. · ...

  • ST-SVI 戦略コンサルタント職

    2ヶ月前

    Tokyo KPMGジャパン/KPMG Japan ￥1,000,000 - ￥2,000,000 per year

    KPMGコンサルティング(KC)について · KPMGは監査、税務、アドバイザリーの3つの分野でサービスを提供するプロフェッショナルファームです。KPMGグローバルでは現在、世界142ヵ国のメンバーファームに約275,000名のプロフェッショナルを擁し、サービスを提供しています。 · ...

  • ST-MES 戦略コンサルタント職

    4週間前

    Tokyo KPMGジャパン/KPMG Japan

    KPMGコンサルティング(KC)について · KPMGは監査、税務、アドバイザリーの3つの分野でサービスを提供するプロフェッショナルファームです。KPMGグローバルでは現在、世界142ヵ国のメンバーファームに約275,000名のプロフェッショナルを擁し、サービスを提供しています。KPMGコンサルティングは、KPMGジャパンのアドバイザリーグループに属し、グローバル規模でのビジネストランスフォーメーション(事業戦略から事業モデルの変革やオペレーションの改善、ITテクノロジーを活用したビジネス改革など)やリスクマネジメントといったコンサルティングサービスを提 ...

  • Sales Operations Specialist

    2週間前

    Tokyo, Tokyo Cybereason Remote job

    Sales Operation Specialist is a high impact role that will afford you the ability to shape our systems and processes for long term sustainability while working with a small agile team. · ...

  • Sales Operations Specialist

    1週間前

    Tokyo Cybereason

    + Sales Operation Specialist is a high impact role that will afford you the ability to shape our systems and processes for long term sustainability while working with a small agile team. · Excellent verbal and written communication skills both in Japanese and English · Ability to ...

  • SME Sales Account Manager

    2ヶ月前

    Tokyo, Tokyo Cybereason ￥4,000,000 - ￥8,000,000 per year

    We are looking for a SME Sales Account Manager to join our team in Tokyo. As a cybersecurity ambassador, you will be responsible for understanding the needs of our customers and providing them with the best solutions to protect their businesses from cyber threats. You will work c ...

  • Workplace Management】Manager, Advisory @ Kioicho, Tokyo

    2週間前

    Shibuya JLL Japan

    + Manage project finances for capital projects within targeted percentage of budget.+ Identify cost savings on all projects. Meet firms' goals for cost avoidance / savings+ Submit timely cost and schedule change requests+ Provide the delivery and management of transition before o ...

  • Manager, Advisory

    3週間前

    Shibuya JLL Japan

    The position is responsible for providing superior client services on FM (Facility Management) and PM (Project Management) consultation.Provide administrative support within the Advisory team and Work Dynamics Account and collaborate with the Sales team to create sales materials ...

  • Manager, Advisory

    3週間前

    Shibuya-ku, Tokyo JLL

    We are seeking an experienced Manager to join our team at Work Dynamics Account Management. As Manager, you will play a key role in providing superior client services on FM (Facility Management) and PM (Project Management) consultation. · Suport transition activities moving smoot ...

  • Workplace Management】Manager, Advisory @ Kioicho, Tokyo

    2週間前

    Shibuya-ku, Tokyo JLL

    The position is responsible for providing superior client services on FM (Facility Management) and PM (Project Management) consultation, and the support for the account team under the transition stage or the lack of key resources. · ...

  • ST-NGU 戦略コンサルタント職

    1ヶ月前

    Tokyo KPMGジャパン/KPMG Japan ￥3,500,000 - ￥5,000,000 per year

    KPMGコンサルティング(KC)について · KPMGは監査、税務、アドバイザリーの3つの分野でサービスを提供するプロフェッショナルファームです。KPMGグローバルでは現在、世界142ヵ国のメンバーファームに約275,000名のプロフェッショナルを擁し、サービスを提供しています。厚生年金保険 · 労災保険 · 退職金制度財形貯蓄制度公認会計士企業年金基金健康保険組合カフェテリアプランワークライフバランス支援制度ベビーシッター育児支援補助病児保育サポート制度保活コンシェルジュサービス保育園費用補助制度屋内原則禁煙 · ...

  • Project Manager(Cronos Study Operations)

    1ヶ月前

    東京都 港区, IQVIA ￥600,000 - ￥1,800,000 per year

    We are seeking a Project Manager to accelerate clinical trial delivery and help bring new treatments to patients faster. As a Project Lead in Cronos Study Operations, you will be part of a core project team responsible for executing clinical studies. ...

  • Sales Operations Specialist

    1週間前

    Tokyo Cybereason Full time

    Cybereason's mission is to protect it all – delivering unparalleled prevention, detection, investigation, and response for all endpoints: workstations laptops mobile devices more · ...