**SITE ACTIVATION業務概要**
Site Activationの業務に関連する治験参加国レベルの業務を実施します。地域および/または国際的な規制要件、標準作業手順(SOP)、プロジェクト要件、および契約上のガイドライン/予算ガイドラインに従います。
メンテナンス作業も含まれる場合があります。
**職務詳細**
- 適用される規制要件、SOP、および作業指示に従って、アサインされた試験の治験実施施設のSite Activation活動を実行します。Site Activation Manager (SAM)やプロジェクトマネージメントチームなどと緊密に連携します。
- 上級スタッフの指導の下、規制文書の作成と完全性、一貫性、正確性を確認し、QCを実施します。
- 各治験実施施設の治験関連文書および契約文書が完成したらチームメンバーに通知します。
- 完成したドキュメントを治験実施施設や社内のプロジェクトチームのメンバーに配布します。
- 社内システム、データベース、治験管理システム、タイムライン、プロジェクトの予定の更新とメンテナンスを実施し、正確で完全なプロジェクトの管理情報となるためのサポートをします。
- 進捗状況、文書の承認と実行、規制要件、倫理、同意説明文書(ICF)、Investigator Pack (IP) release documentsの内容のレビュー、進捗管理、フォローアップします。
**必須経験**
- 事務的職種での3年の経験、または同等の教育、トレーニング、経験。
- 細部まで取り組む業務処理能力と複数プロジェクト管理能力。
- 優れた文書処理とMS Officeアプリケーションの知識。
- 優れたコミュニケーション能力。同僚、マネージャー、スポンサーとの効果的な仕事上の関係を確立し、維持する能力。
**推奨給与**: 年間 ¥6,000,000相当
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