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Jobs at Parexel

Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.

Clinical Development Risk & Compliance Manager/クリニカル・デべロップメント・リスク &コンプライアンス・マネジャー

Job ID R0000043501 Tokyo, Tokyo, Japan

【職務概要】

臨床試験におけるリスクおよびコンプライアンスマネジメントのスペシャリストとして、プロジェクトおよびアカウントレベルでリスクマネジメントをリードします。Quality Risk Evaluation(QRE)、ダッシュボード、メトリクス、予測ツールを活用した先制的なリスク分析から、複雑なデータの可視化、実行可能なインサイトの提供、そして長期的な改善戦略の推進まで、幅広い職務を担当します

【具体的な業務】

  • プロジェクト/アカウント単位でのリスク管理やプロセスのリード

  • クロスファンクショナルチームと連携し、リスクの特定・優先順位付け・対策実行

  • QRE(Quality Risk Evaluation)などを使ったリスク分析・データ活用・予測

  • CAPA(是正予防措置)

  • Root Cause Analysisの推進

  • SOP逸脱やクオリティイシューの対応・調査・改善

  • 監査・査察対応(audit/inspection readinessの維持)

【必須経験・知識】

  • 臨床研究における8年以上の実務経験

  • Quality またはRisk Management活動における実証的経験

  • ICH-GCPの知識

  • 英語:ビジネスレベル上級(口頭・書面)

【歓迎される経験】

  • PMDA対応経験、査察対応経験

【このポジションの魅力】

臨床開発プロジェクトのリスクマネジメントおよびコンプライアンスの中核を担い、単なるクオリティチェックに留まらず、リスクの予測・分析・改善までをリードする戦略的ポジションです。さらに、リスクマネジメントおよびクオリティ領域の専門性を高めながら、グローバルかつマトリックス組織の中で影響力を発揮し、主体的にキャリアを発展させることができます。

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