Senior Lead Data Manager
- Japan
- Clinical Data Management, Clinical Data Scientist Lead, Clinical Systems, Data Standards Consultant
- ICON Strategic Solutions
- Remote
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。
臨床試験におけるClinical Data Coordinator(CDC)として、クリニカルデータマネジメントシステム(CDMS)の構築に関連する仕様書作成、データレビュー活動のリード又はサポート、データ及び成果物提供前のレビュー活動をLead Data Managerの指示のもと実施いただきます。
※能⼒・実績に応じて、将来的に上級職(Lead Data Manager)への職種変更も可能です
【職務詳細】
CDMS 構築の仕様書作成(画面設計、Edit Check 仕様書、UAT スクリプト等)
EDC/eCOA の UAT の実施
Data Management Plan の作成、維持管理
データレビュー(外部データとの Reconciliation 含む)
クエリ発⾏、管理
Study Lock/Unlock 業務
SDTM のテストデータの作成
クライアントへの提供前の各種資料やデータセットのレビュー
信頼性調査対応
■応募資格
臨床試験のデータマネジメント業務(EDC 構築〜データ固定まで)経験が 3 年以上あること
EDC の使用経験を有すること
英語のドキュメントが読め、簡単な文書・メールを作成できるレベルの英語⼒を有すること
円滑なコミュニケーションスキル及び対人折衝スキルを有すること
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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