Regulatory Submissions Manager - Osaka, Japan

部門紹介 Centralized Monitoringチームは、主にRisk Based Monitoring （RBM)における中央モニタリングに関連するサービスを提供する部署です。クリニカルチームや顧客とのコミュニケーションを通じて、RBM適用プロジェクトをマネージする役割を担っています。また、データに基づくモニタリングを推進するため、CRAを支援するための社内サービスを提供しています。 仕事内容 ■職務概要 PythonやVBA、SASなどのプログラミング言語やBIツールを使用して、社員の業務効率化に係わるプログラムやツールを開発する業務 ■職務詳細 • BIツールを使用したグラフやリスティングの開発(仕様書作成やバリデーション含む) • データの集計プログラムの開発(仕様書作成やバリデーション含む) • 定型作業を自動化するプログラムの開発等

CRAの直属の上司として、CRAのピープルマネジメント及び、医薬品の臨床開発において以下の重要な役割を担って頂きます： ■CRAを期待されるレベルに到達させるため、適応となるSOP、規制要件及びガイドラインの教育を行い、プロジェクトの品質を向上させる。 ■医療機関への同行及びモニタリング報告書のレビューにより、CRAのパフォーマンス評価並びに指導を行う。 ■CRAの実施医療機関に対する業務計画及び実行状況について、決められたタイムライン通りに実施出来ていることを監督する。 ■医療機関で発生した重要な問題の解決、是正措置及び予防措置の構築をサポートする。 ■CRAの目標設定及び中長期的なキャリア開発をサポートする。 ■状況報告のため、海外及び日本の治験依頼者との定期的なテレカンファレンス実施する。 【特徴】 取引先：大手外資系製薬メーカー 領域：オンコロジー領域、再生医療など最先端分野 実施試験：全てグローバル試験 監督するCRA数：最大12名

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 core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and our suite of solutions to drive operational excellence and strategic leadership with our customers Essential Functions • Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies. • May be responsible for delivery and management of smaller, less complex, regional studies. • Develop integrated study management plans with the core project team. • Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures. • Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance. • Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. • Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally. • Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts. • Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans. • May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with our business development representatives, as necessary.; • Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.; • Ensure the financial success of the project. • Forecast and identify opportunities to accelerate activities to bring revenue forward. • Identify changes in scope and manage change control process as necessary. • Identify lessons learned and implement best practices. • May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.; • Adopt corporate initiatives and changes and serve as a change advocate when necessary. • Provide input to line managers of their project team members’ performance relative to project tasks. • Support staff development and mentor less experienced project team members on assigned projects to support their professional development.;

Efficiently manage and successfully execute all aspects of global project start-up; Perform quality checks on submission documents and site essential documents; Prepare and approve informed consent forms; Review pertinent regulations to develop proactive solutions to start-up issues and challenges; Present during bid defenses, general capabilities meetings, and audits.