Summary of purpose/major responsibilities The Clinical Operations and Study Leader (COSL) combines Clinical project and study oversight roles and responsibilities for Vaccines projects activities. For projects activities (project and study oversight, CTD submission, PAI…), the COSL will cover both
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. PSI is a leading Contract Research Organization with more
Job title: Clinical Operations Study Country Lead (COSCL) Location: Tokyo, Japan About the job Our Team: We are seeking a highly motivated and experienced Clinical Operations Study Country Lead to support local clinical trial operations. The COSCL will be a strategic leader
Job Overview: A key operational role within our matrix organization, accountable for the clinical operational activities and performance within an assigned group of countries or delivery team, with responsibilities for customer connections and commercial activity. Leading a
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every clinical development
Site Contracting - Tokyo Osaka - Office Hybrid Home ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity,
Clinical Pathway Capability Specialist Location: Tokyo Department: Sales Job type: Full Time Join us and make a difference when it matters most! At Mundipharma, we are proud of the work we do to bring innovative treatments to
Payment Specialist - Tokyo Osaka - Office Hybrid Home ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity,
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
1. Objectives Responsible for clinical development of the assigned project in Japan under the supervision of the Japan Development Leader (JDL), who assumes responsibility for development of all projects in Japan in the respective therapeutic/disease area (TA/DA).
General Information Job Advert Title: Medical Operations Specialist, Medical Affairs, Japan Location: Nihonbashi,Tokyo Division: Medical Affairs Regions Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company committed to turning innovative science into VALUE
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
臨床試験の運営をリードするポジションとして、グローバルチームや外部パートナーと連携しながらプロジェクトを推進します。試験の進行管理・品質確保・リスク対応まで幅広く担当する役割です。 企業情報 グローバルに事業を展開する医薬品関連企業で、臨床開発および医療ソリューションに関する事業を行っています。複数の専門領域のメンバーが在籍しており、各種プロジェクトにおいて協働しながら業務を進める体制です。 職務内容 * 臨床試験（初期〜後期フェーズ）の運営および進捗管理 * 社内外の関係者（グローバルチーム・CRO・ベンダー）との連携および調整 * プロジェクトのスケジュール・予算・リソース管理 * 臨床関連文書の作成・レビューおよび管理（TMF含む） * KPIを用いたパフォーマンスモニタリングと報告 * リスクの特定・対応策の策定およびエスカレーション対応 * 規制当局への提出資料関連業務のサポート * GCPに基づく品質管理および査察対応のサポート 理想の人材 * 製薬企業またはCROにおける臨床試験関連の業務経験 * 臨床プロジェクトの進行管理またはモニタリング経験 * ベンダーまたは外部パートナーのマネジメント経験 * 日本のGCPや関連規制に関する理解 * 英語を用いた業務遂行能力（グローバルとのコミュニケーション） 条件・待遇 * 各種社会保険 * 在宅勤務制度
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),
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
The Japan Project Head (JPH) would be responsible for overall Japan development strategy for vaccine project in alignment with Global project strategy as well as Sanofi R&D strategy and business objectives. The JPH is accountable for
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
The Team Lead, Global Regulatory Affairs CMC - Japan is responsible for providing strategic leadership and operational oversight for the Global Regulatory Affairs CMC - Japan team. Reporting to the Head of Global Regulatory Affairs CMC