大阪市, 日本, Santen

会社概要

Santenは、眼科医療に特化した130年の歴史を持つ製薬企業です。日本発のグローバル企業として60カ国以上に拠点を持ち、目の健康のために様々な革新的な治療法とデジタルソリューションを提供し、世界中の人々の視覚に関わる社会問題に取り組んでいます。

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.

求人内容

Product Development Systeme Managementチームは、主に臨床試験を実施する上で必要なeTMFやCTMS等のシステムについてグローバルで導入、管理、運用する役割を担っています。

臨床試験で使用するシステムについて、導入、設定変更、運用整備を他のメンバーとグローバルで連携して実行いただきます。また、各臨床試験の実施時には主に中国での試験を担当する現地担当者やCRO担当者と連携してシステムの適切な運用管理の役割を担っていただきます。

1. Veeva Vault Clinical Systemの専門家として、以下のシステム管理、運用の役割を上位者の指示に従い担う。

1) システムの導入、バージョンアップ時の設定変更におけるCSVの各種役割

2) 社内外のシステムユーザーを対象としたトレーニング及び運用サポート

3) System Operation Plan, Training Plan, User's guide, SOPなどの文書の作成、改訂

4) TMF specialistとしてeTMFシステムの運用、文書管理

5)  監査、GCP査察時のシステム関連の対応

2. その他、研究開発関連システムについての運用、管理サポートを担う。

資格

必要経験・スキル:

・CRA, QC, QAなどで1年以上のICH-GCP関連業務の経験があり、治験プロセスを理解している。

・ビジネスレベルの日本語、中国語力が必須(英語力があるとより望ましい)

歓迎要件:Veeva Vault製品の使用経験(eTMF, CTMS, VQD, GRDSなど)及びGCP文書管理経験

CSV (Computerized system validation)の経験

人像:

・関連部門担当者との円滑なコミュニケーションが取れる(海外対応あり)

・問題点を的確かつ客観的に判断できる。

・自律的に計画通りの業務の進捗を図ることができる。

・複数のプロジェクトを管理/優先順位付けできる能力。

その他の情報

(業務内容の変更の範囲)当社業務全般

(就業場所の変更の範囲)本社および全国の事業所、営業所



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