About us BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse
Job Description SummaryStudy Start-Up Managerは、ノバルティスのプロセス、GCP/ICH、及び国内における規制要件に従って、試験の計画、スタディスタートアップ業務を担い、プロジェクトのスタディスタートアップに関する成果物に対しての責任を負います。 また、国内の開発プロジェクトチーム及びグローバルスタディチームと連携し、担当プロジェクトのスタディスタートアップ業務をリードします。 Job Description Accountabilities 国内の開発プロジェクトチームと連携し、国内のスタディスタートアップ戦略をサポートします。 国内の開発プロジェクトチーム及びグローバルスタディチームと協力し、国内のスタディスタートアップのスケジュール及び成果物が達成されるようにします。 プロジェクトにおいて、Green Light(治験実施医療機関が開始する準備ができる)まで、タイムリーなスタートアップ業務に説明責任を負います。 必要に応じて、IRB/IECへの提出資料の作成、同意説明文書のレビュー及び規制当局への提出、試験の開始業務が予定通りに実施及び完了できることを確認します。 IRB/IEC及び該当する場合は規制当局に提出するために、国内の提出資料を作成します。 TMF監査への準備を確実にするため、試験開始時の国内のTMF文書のスケジュール、正確性、品質について説明責任を負います。 財務基準、現行の規制、ICH/GCP、IRB/IEC、規制当局、SOPの要件を確実に遵守します。 ノバルティスの戦略に沿った革新的かつ効率的なプロセスを実行します。 Feasibility Manager及びSite Partnership Manager、並びにグローバルスタディマネージャーと連携し、試験の実現可能性をサポートします。 既に任命されている場合は、Portfolio Team Lead及びClinical Project Managerと協力して治験実施医療機関の選定をリードします。 スタディスタートアップフェーズにおける品質/コンプライアンス問題の主要なコンタクト先としての役割を果たし、必要に応じてエスカレーションします。 治験実施医療機関が「Green Light」に備えていることを確認し、初回及びその後の治験薬出荷のための全ての文書が整備されていることを確認します。治験実施医療機関の「Green Light」のレビューと承認に責任を負います。 ノバルティスの基準および国内外の規制に従い、スタートアップのスケジュールと品質を確保するために、国内のスタディスタートアップチームの活動を管理し、実施します(必要に応じて是正措置を提案します）。 国内のスタディスタートアップチームミーティングの主導/進行役を務め、必要に応じてグローバルスタディミーティングに参加します。 Study Start-Up CRA、Clinical Project Manager、Study Start-up
Associate Manager / Medical Advisor, Medical Affairs, Consumer Health YOUR TASKS AND RESPONSIBILITIES: Responsible for scientific and medical communication plans including material development, publications, MSL’s, etc. Develops and guides local Thought Leader (TL) management strategy. a.
Job Description: Key responsibilities: Evidence Generation Leadership Lead the development and execution of evidence-generation plans that address critical scientific, clinical, health economic, and market access evidence gaps across the product undefined Design and oversee Phase IIIb/IV
About Woven by Toyota Woven by Toyota is enabling Toyota’s once-in-a-century transformation into a mobility company. Inspired by a legacy of innovating for the benefit of others, our mission is to challenge the current state of
MAIN REPONSIBILITIES / DUTIES JOB POSITION PURPOSE The MAS roles are hybrid in responsibilities. Specific roles in teams can vary between 80% field with 20% head office activity to 80% head office activity with 20% field
Join ispace as a Propulsion Design Engineer and help shape the future of lunar exploration. We’re looking for a passionate engineer with broad experience in the mechanical design of spacecraft propulsion systems—someone excited about tackling complex
Job Description Bring It You bring over 15 years of experience as a solution architect in Defense & Security. Your SAP background covers defense solutions or logistics, and you know how defense organizations operate. You work
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Pacifico Energy develops, finances, builds, and operates energy infrastructure that powers businesses and communities. In the U.S., we are tackling one of the biggest challenges facing AI and large-scale data centers: access to reliable power. Our
Pacifico Energy develops, finances, builds, and operates energy infrastructure that powers businesses and communities. In the U.S., we are tackling one of the biggest challenges facing AI and large-scale data centers: access to reliable power. Our
Job Scope: Provide strategic and operational leadership for post-marketing surveillance (PMS) activities for assigned products and programs in Japan. Lead PMS strategy, study planning, execution oversight, and quality oversight in compliance with GPSP regulations. Author, review, and
Who We Are:IMG is a leading global sports marketing agency, specializing in media rights management and sales, multi-channel content production and distribution, brand partnerships, strategic consulting, digital services, and event management. It powers growth of revenues,
Locations: Tokyo, Japan Categories: Clinical Trial Management Req ID: 13087 Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Site Relationships Coordinator to join our Clinical Trial Management team in Tokyo,
企業概要 Sika is a specialty chemicals company with a globally leading position in the development and production of systems and products for bonding, sealing, damping, reinforcing, and protection in the building sector and industry. Sika has
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
We support peace and prosperity by building connections, understanding and trust between people in the UK and countries worldwide. For over 90 years we have shaped brighter futures through education, arts, culture, language, and creativity. We
Regional Facilities Planner The Opportunity: As a facilities professional, you understand coordination and attention to detail when overseeing the life cycle of a project. Client engagement skills impact projects, and you are responsible for using them
Basic purpose of the job The local Head of Real Estate & Facility Management is end-to-end accountable for the overall development and execution of the Real Estate & Facility Management function in the site. This includes:
Position:Applications Engineer ll Job Description: Principal Accountabilities Produce new software applications for our warehouse applications team. Evaluates progress and results of development efforts. Execute, assess, and troubleshoot software programs and applications. Analyzes and amends software errors