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 Major 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
Come join the organization that is redefining security for the AI era. As one of the fastest-growing startups ever, we enable teams to secure cloud and AI applications by connecting code, cloud, and runtime into a
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Step into a career with ASM, where cutting edge technology meets collaborative culture. For over 55 years ASM has been ahead of what’s next, at the forefront of innovation and what’s technologically possible. With more
About Remote Remote is solving modern organizations’ biggest challenge – navigating global employment compliantly with ease. We make it possible for businesses of all sizes to recruit, pay, and manage international teams. With our core values
About Remote Remote is solving modern organizations’ biggest challenge – navigating global employment compliantly with ease. We make it possible for businesses of all sizes to recruit, pay, and manage international teams. With our core values
About Remote Remote is solving modern organizations’ biggest challenge – navigating global employment compliantly with ease. We make it possible for businesses of all sizes to recruit, pay, and manage international teams. With our core values
About Remote Remote is solving modern organizations’ biggest challenge – navigating global employment compliantly with ease. We make it possible for businesses of all sizes to recruit, pay, and manage international teams. With our core values
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At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
Step into a career with ASM, where cutting edge technology meets collaborative culture. For over 55 years ASM has been ahead of what’s next, at the forefront of innovation and what’s technologically possible. With more
Job Title:Lead, Automation & Controls Engineer Job Description: THE ROLE We are seeking a Lead, Automation and Controls Engineer to drive the design, development, and optimization of advanced automation systems across our manufacturing site in Yonezawa,
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