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臨床研究スペシャリスト// Clinical Research Specialist

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外資系医療機器メーカーにて、臨床研究スペシャリストの募集です。治験の安全性・信頼性を担保し、日本の規制に適合した効率的な試験運営を支えるための業務をご担当いただきます。月1回の出社が必要なハイブリッドポジションです。勤務地は東京都もしくは大阪府です。

職務内容:

  • 治験、市販後臨床研究および市販後調査の計画・実施・進捗管理と報告書作成
  • 担当施設における手続き業務、モニタリングならびに監査対応
  • 関連文書の作成および確認
  • 内部・外部関係者との良好な関係構築
  • 重篤有害事象や逸脱の報告と対応、および医療機器の不具合報告と対応

必須要件:

  • 大卒（医学、薬学、看護学、生命科学、工学関連分野尚可）
  • 医療機器会社、製薬会社、またはCROでの治験モニター経験
  • 大学病院等の基幹病院の担当経験
  • GCPに関する深い知識
  • 英語でのSOPや業務関連文書の読解、モニタリング報告書作成スキル
  • 日本での就労資格

歓迎要件:

  • チームリーダーの経験
  • 新人やジュニアモニターの育成経験
  • 担当試験の疾患領域におけるKOLマネジメント経験 （KOL施設担当モニター含む）
  • ISO 14155の知識

会社概要:

医療技術や医療機器を提供する外資系医療機器メーカー。心疾患、神経疾患、慢性疾患など幅広い治療領域に向けた製品やソリューションを展開しています。

求人番号: A7UFU6

About the job

Contract Type: Perm

Specialism: Healthcare

Focus: Clinical Research

Industry: Medical and Nursing

Salary: ¥5,000,000 - ¥8,000,000 per annum

Workplace Type: Hybrid

Experience Level: Associate

Language: Japanese - Professional working

Location: Osaka

Job Reference: A7UFU6-9EDB6217

Date posted: 8 May 2026

Consultant: Samin Hoque

Phone number: +81 6-4560-3108

samin.hoque@robertwalters.co.jp

Samin Hoque

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