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
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