CDC Ⅱ
- Japan
- Clinical Data Management, Clinical Data Scientist Lead, Clinical Systems, Data Standards Consultant
- ICON Strategic Solutions
Talent Acquisition Team Lead
- Icon Strategic Solutions
About the role
・成長性の高い両社の統合により、世界で1-2位を争う規模のグローバルCRO(世界で40,500名規模、日本で1,000名規模)に拡大・補完的な統合にもとづく、クライアントポートフォリオの多様化がもたらす本格的なスケールメリットの実現
・さまざまな疾患領域への深い知識をはじめとする、両社が育んできた強みを活かした幅広い/質の高いソリューションの提供・最先端のテクノロジーに、スケールメリットが加わることで、より患者さん中心の新しい臨床開発オペレーションを業界内で牽引
・ビジネス機会の拡大・多様化に伴う、従業員に対する幅広いキャリア・能力開発の機会を提供今後も業界内において、ますますの大きな変化(合従連衡や臨床開発のオペレーションそのものの変革)が予想されます。
臨床試験(治験)における Lead Data Manager(LDM)としてのデータマネジメント業務をお任せします。
【具体的には】
■マネジメント業務
・顧客及び関連部門の窓口
※Projectにおけるデータマネジメント業務に係る下記業務
・工数及び所要時間の見積もり
・Financial Documentationのレビュー
・Timelinesの作成
・進捗及び予算の管理
■ハンズオン業務
・Protocolレビュー
・Data Management Planの作成、維持管理
・Local Lab Conventionsの作成、維持管理
・Third-Party Data Transfer Specificationsの作成
・Clinical Systems Solutionsに関する計画 (Core Configuration Setup, Targeted Source Data Verification, Clinical System Design Guideのレビュー)
・Data Review Activitiesの計画
・CRF Completion Guidelinesの作成 ・レビュー
・Edit Check Planの作成 ・レビュー
・Clinical Data CoordinatorのOversight(データレビューおよびクエリ管理を調整し完了させる。)
・Data Validation OutputsがRequirementsに適合性しているかのレビュー
・運用中のClinical System Solutionsの変更管理
・Data Delivery Checklist及びData Delivery Approval Formの作成・レビュー
・Study Lock/Unlockの実行及び管理
・データマネジメント計画書遵守状況の評価
・会議の参加及びデータマネジメント会議のホスト
・信頼性調査対応
・大学卒(医薬、獣医、農学、生命科学等の学部学科)、または医療系(看護師、臨床検査技師等)の資格保有者
・臨床試験(治験)の一連のデータマネジメント業務(EDC構築~データ固定まで)について5年以上 のご経験
・EDC構築のご経験
・経験の浅いデータマネジャーの教育、サポート、マネジメントが可能な経験・知識
・CDISC標準に関する知識
・海外関係者との折衝等が円滑に行えるレベルの英語力を有すること(目安TOEIC 750点以上)
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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