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Senior Clinical Data CDC

  1. Japan
2024-109122
  1. Clinical Data Management, Clinical Data Scientist Lead, Clinical Systems, Data Standards Consultant
  2. ICON Strategic Solutions (FSP)

About the role

This vacancy has now expired. Please click here to view live vacancies.

・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

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