( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
職務 概要 Position Summary : 富士 New Product Introduction(NPI)/Packaging Specialist ( Project Management /Engineering )は以下職務を行う。 The New Product Introduction(NPI)/Packaging Specialist ( Project Management /Engineering ) for as follow l 富士工場新製品導入のガバナンス,プロジェクトの実施 Execute governance and project for Fuji
Works directly with GRA Leadership, GRA personnel, as well as PMO and Finance in leading the project review process, raising issues for resolution, ensuring action items are completed, and communicating the health of both project and
As Senior Technical Editor(Or Senior Editor), you will in charge of the editorial work, including collection, classification, and analysis of law-related information in general, and leads this work by linking the information and enhancing the content
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be part
Responsibilities Noblis MSD’s mission is to support the Naval Sea Systems Command (NAVSEA) objectives to design, build, deliver and maintain ships, submarines, and systems reliably, on-time and on-cost for the Navy. We are looking to hire
Responsibilities Noblis MSD’s mission is to support the Naval Sea Systems Command (NAVSEA) objectives to design, build, deliver and maintain ships, submarines, and systems reliably, on-time and on-cost for the Navy. We are looking to hire
Job Description Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Job Description At Thermo Fisher Scientific, each one of our 125,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and
SUMMARY Responsible and accountable for Medical Affairs strategy of Urological cancer products C ollaborates with internal and external stakeholders including key opinion leaders to develop and implement the overall M edical Affairs strategy for product lifecycle
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people worldwide.
Job Overview Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the
About BHP At BHP we support our people to grow, learn, develop their skills and reach their potential. With a global portfolio of operations, we offer a diverse and inclusive environment with extraordinary career opportunities. Our
About BHP: At BHP we support our people to grow, learn, develop their skills and reach their potential. With a global portfolio of operations, we offer a diverse and inclusive environment with extraordinary career opportunities. Our
* This position will be responsible for managing assigned clinical studies globally and locally, overseeing study activities, budgets, timelines, and vendor relationships. * The role involves leading a multifunctional team, ensuring adherence to regulatory requirements, managing
Take lead in QC for quality tests and designs. Ensure proper documents and regulatory requirements are correct. Client Details * One of the leading global pharmaceutical companies in the industry * Specializing in Immunology, Neurology, and
* Contribute to the development of innovative cancer therapies by working collaboratively with R&D, program management, clinical operations, biostatistics, and data management teams * Contribute to the clinical strategy and development plans for various oncology indications * Provide
* Responsible for supporting the Project Management group to ensure smooth and effective study delivery through organising of important documents and files. Client Details * European headquartered, pharmaceutical company with a mission to help patients with
Leading the local trial team to deliver results compliant with assigned protocols, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements. Actively contributing to process improvement and site management, you will train
Take lead in QA activities for the companys site to ensure effective compliance. Manage manufacturing products are up to date aligning with QMS. Client Details * One of the leading global pharmaceutical companies in the industry
