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
Part-Time Veterinarian | Kwinana Veterinary Hospital Picture stepping into a clinic where you can settle in quickly, know the people beside you and genuinely feel like your experience is valued. At Kwinana Veterinary Hospital, we’re entering
Company Description Strategy (Nasdaq: MSTR) is at the forefront of transforming organizations into intelligent enterprises through data-driven innovation. We dont just follow trends—we set them and drive change. As a market leader in enterprise analytics and
Help us use technology to make a big green dent in the universe! Kraken powers some of the most innovative global developments in energy. We create the technology that redefines utilities and unlocks a new energy
Primary Function Source, interpret, generate, and communicate high-quality, timely real-world evidence and insights to inform business decisions across therapeutic areas and serve as an RWE expert in engagements with external stakeholders. § Lead RWD analyses and
About Anthropic Anthropic’s mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a quickly growing
場所：AlphaSights東京オフィス Location: AlphaSights Tokyo Client Service Associate への本選考を受ける準備として、ワークショップイベントを開催します。 イベントでのパフォーマンスに応じて、特別選考プロセスにご招待します。 Are you looking for an opportunity to jump into a real working space? Autonomy, high personal impact, and an introduction to the world of business without pigeonholing
Overview: The Client Service team connects Guidepoint’s clients with subject-matter experts to better inform their business decisions. They take the time to understand each client’s specific research needs and deliver the experts closest to the topic,
This is Adyen Adyen provides payments, data, and financial products in a single solution for customers like Meta, Uber, H&M, and Microsoft - making us the financial technology platform of choice. At Adyen, everything we do
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
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
Company Description Since its spin-off in September 2025 AUMOVIO continues the business of the former Continental group sector Automotive as an independent company. The technology and electronics company offers a wide-ranging portfolio that makes mobility safe,
Help us use technology to make a big green dent in the universe! Kraken powers some of the most innovative global developments in energy. We create the technology that redefines utilities and unlocks a new energy
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to
Job Family Group: Sales Group Job Description: • This role is to manage existing distributors and drive growth in designated area thru applying Castrol’s value selling approach • Actively promote focused products (e.g. XBB, Syntilo) along
Minimum qualifications: Bachelors degree or equivalent practical experience. 5 years of experience working with digital media or digital marketing/advertising solutions, implementing and measuring digital advertising campaigns, and providing client solutions. Experience with SQL or scripts, building
POSITION Executive Coordinator DEPARTMENT Enrollment Management POSITION TYPE Full-time LOCATION City Campus (Sangen-jaya station): Limited hybrid-remote flexibility may be available, depending on the nature of the role and operational needs. WORK HOURS 37.5 hours per week
You desire impactful work. You’re RGA ready RGA is a purpose-driven organization working to solve today’s challenges through innovation and collaboration. A Fortune 200 Company and listed among its World’s Most Admired Companies, we’re the only