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
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
Basic Purpose of the Job The Clinical Program Leader assumes Clinical Development responsibilities supporting early or late development projects, reporting to the Associate Global Head or the Global Clinical Programme Team Leader. The Clinical Program Leader has a medical leadership
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
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
Career CategoryClinical Development Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all
Job Purpose The Clinical Scientist (CS) in Japan is responsible and accountable for clinical scientific outputs for assigned projects and studies in Japan. The CS will have accountability for approximately 2 - 4 projects (assets) at any one
Job Purpose The Clinical Development Lead (CDL) in Japan is the single point of accountability for all clinical development activities for assigned asset(s). The CDL provides scientific and medical leadership to define and deliver Japan clinical strategy, drives innovation
General Information Job Advert Title: Clinical Site Manager Ⅲ（臨床開発モニター/ Site Monitor/ CRA） Location: Nihonbashi, Tokyo Division: Clinical Operations, Quantitative Sciences and China Development Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company committed to turning
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
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 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
Basic Purpose of Job Manage case processing activities for Nippon Boehringer Ingelheim’s investigational and marketed products including case submission to Global Patient Safety and Pharmacovigilance (PSPV) and PMDA according to Boehringer Ingelheim (BI)’s internal procedure and
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice, Warehouse Job Description Essential Duties and Responsibilities Understand key business drivers and leverage knowledge of the regulatory framework and environment in Japan to propose regulatory solutions that enable the delivery of
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