スタディマネジャー/Japan Study Manager

1ヶ月前

Tokyo Pfizer

Japan Study Manager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

  • スタディマネジャー/Japan Study Manager

    1ヶ月前

    Tokyo Pfizer ￥2,652,480 - ￥5,520,000 per year

    A Study Manager will manage clinical trials within Japan by overseeing site health and ensuring timely delivery of quality data. · ...

  • 東京 スタディマネージャー(Study Manager:SM)

    7日前

    Tokyo イーピーエス株式会社 ￥6,000,000 - ￥9,000,000

    +モニタリング業務(全て又は一部)の実施及び管理を行っていただきます。契約事項、GCP、SOP、その他関連する法規制等を遵守し、受託したプロジェクトにおけるモニタリング業務全般の実施、またその業務全般の管理を行う責務を担っていただきます。 · +育児休暇制度/介護休職制度/財形貯蓄/その他制度/確定拠出年金401k/社員持株会制度 · +OncologyおよびGlobalStudy経験がある方 · ・他社CROあるいはメーカーにて、CTLないしは同種の業務の実績がある方 · ・GlobalStudyのLSM経験、もしくは製薬会社で試験計画の企画立案経驗を ...

  • Customer Success Manager, Japan

    6日前

    Tokyo, Japan FoundryのCustomer Success Manager, Japanの求人応募 ￥2,500,000 - ￥5,000,000 per year

    +About the Role As the Customer Success Manager you will collaborate closely with our team of skilled sales representatives to expertly set up meticulously track and precisely report on the cutting-edge digital programs we're executing for technology clients This presents an exce ...

  • Japan Manager

    4週間前

    Tokyo, Tokyo OneBev - One Beverage ￥60,000 - ￥180,000 per year

    We are looking for a Japan Manager to expand our presence in Japan by developing new importers, customers and channels. The ideal candidate will have a minimum of 5 years' professional experience in the Japanese wine industry, with a proven track record in wines sales in Japan an ...

  • Manager - Japan

    4週間前

    Tokyo dss+ ￥60,000 - ￥120,000 per year

    We are not just your average operations consulting firm; we implement and change. Our passion lies in engaging organisations to craft resilient and sustainable business, · We take the complex world of risk and sustainability and translate it into actionable roadmaps that work wit ...

  • Manager - Japan

    4週間前

    Tokyo, Tokyo dss+ ￥6,000,000 - ￥12,000,000 per year

    We are not just your average operations consulting firm; we are implementers and change makers. Our passion lies in engaging organisations to craft resilient and sustainable business, guiding them through transformational changes in safety, risk and resilience and through their e ...

  • Japan Study Manager, Study and Site Operations Group

    2ヶ月前

    Tokyo Pfizer Full time￥6,000,000 - ￥12,000,000 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. · Res ...

  • Japan | Client Services Manager, Japan

    2ヶ月前

    Tokyo WPP ￥4,000,000 - ￥12,000,000 per year

    Client Services Manager at WPP in Tokyo, Japan. The role involves building strong relationships with clients, managing expectations, and ensuring deliverables meet client expectations. · Drive relationships with day-to-day clients and confidently field and manage requests, input ...

  • Country Manager, Japan

    4週間前

    Tokyo Streamax ￥3,000,000 - ￥5,000,000 per year

    +About Streamax's International Business Division · + · +ResponsibilitiesDevelop and execute Streamax's business and go-to-market strategy for Japan to achieve sustained growth and profitability. Build and manage strategic partnerships with OEMs, Tier-1 suppliers, · ,system integ ...

  • Marketing Manager, Japan

    6日前

    Tokyo, Japan Pure Storage

    +We're in an unbelievably exciting area of tech and are fundamentally reshaping the data storage industry. · ++ Generate opportunities/pipeline and accelerate their sales stages through various demand generation marketing activities, including in-person events, executive engageme ...

  • Manager, Japan Regulatory

    1ヶ月前

    Tokyo TD $120,000 - $180,000 per year

    The Manager, Japan Regulatory will support the governance for the Japan asset management entity. The role will support the creation and on-going governance for the intermediation activities happening in Japan on behalf of TDAM and TD Epoch. The role will provide advice and guidan ...

  • Team Manager – Japan

    2ヶ月前

    Tokyo, Tokyo MedHub-AI ￥6,000,000 - ￥12,000,000 per year

    We are seeking an experienced Team Manager to lead our Japan field and clinical teams, ensuring installation, clinical support, and commercial operations run seamlessly across hospitals nationwide. · Lead and structure field engineers and clinical specialists to ensure high perfo ...

  • Manager - Legal Japan

    4週間前

    Greater Tokyo Area adidas ￥600,000 - ￥1,800,000 per year

    Provide excellent legal services to adidas Japan including strategic legal advice and operational support for functions within the Japan market. · ...

  • Marketing Manager, Japan

    1ヶ月前

    Tokyo ELSA, Corp ￥4,000,000 - ￥8,000,000 per year

    We are seeking a Marketing Manager, Japan who will own country-level marketing programs with a primary focus on influencer marketing, while also supporting paid media and CRM initiatives. · Develop and execute end-to-end influencer programs in Japan across YouTube, TikTok, Instag ...

  • Country Manager, Japan

    1ヶ月前

    Tokyo New Relic ￥6,000,000 - ￥15,000,000 per year

    +b>Job summary:/ · New Relic is looking for a dynamic Country Manager to drive commercial growth and expansion in Japan.+ · ++Maket strategy anbd growth: Develop anad execute a Japane-specific go-to-market strategt that aligns with global objectives. · +Owen revenue groth: Drive ...

  • Product Manager, Japan

    1週間前

    Tokyo, Japan Canva ￥3,000,000 - ￥6,000,000 per year

    Join the team redefining how the world experiences design. · Thanks for stopping by. · ...

  • Country Manager Japan

    2ヶ月前

    Tokyo Ultimate Asset ￥9,000,000 - ￥12,000,000 per year

    As part of the company's continued APAC expansion, they're seeking a Country Manager to launch and lead the Japanese market. · Develop and execute a comprehensive sales strategy to drive adoption across agencies, brands, and media owners in Japan · Establish a compelling market p ...

  • Japan HR Manager

    2ヶ月前

    Tokyo GENEWIZ from Azenta Life Sciences ￥900,000 - ￥1,200,000 per year

    As the HR business partner for Japan, you will be responsible for supporting the company's rapid growth in the Japanese market, enhancing employee engagement and retention, and strengthening leadership capabilities within the management team. · Bachelor's degree or higher in Huma ...

  • Manager, Finance, Japan

    3日前

    Greater Tokyo Area Mapletree ￥2,000,000 - ￥2,500,000 per year

    The RoleThis position will be responsible for assigned portfolio in the Finance Department. · ...

  • Sales Manager, Japan

    2週間前

    Tokyo Fanatics ￥900,000 - ￥1,200,000 per year

    Responsible for driving sales and margin performance for Topps International in Japan through building and optimizing relationships in the Retail Convenience sector. · Oversee and grow the Retail Convenience partnerships in Japan, achieving defined KPIs · Analyze local market cap ...

  • Distribution Manager in Japan

    2ヶ月前

    Tokyo Signify

    We're looking for a Logistics Manager to join our Distribution team in Japan. · ...