Associate Clinical Research Director providing medical expertise to clinical studies and supporting development activities in a global biopharmaceutical company. Collaborating with stakeholders to ensure optimal study execution.
About the role
- Clinical Research Specialist collaborating with CRMS to oversee clinical studies in Japan. Responsible for managing relationships and ensuring compliance in clinical trials.
Responsibilities
- 日本のCRMS部門(Clinical Research & Medical Science)と連携し、臨床研究の推進を支える重要な役割を担います。
- 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
- その他、組織やプロジェクトに必要な業務
Requirements
- 医療機器会社、製薬会社、またはCROでの5年以上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
- 高いコンプライアンス意識と品質意識
- 循環器や心臓血管領域の担当経験
- 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
- ISO 14155の知識
Benefits
- 年間最大36万円の育児費用補助
- 家族に介護が必要になった場合や養子縁組の際などに6週間取得できる休暇制度
- ベビーシッターや保育園のマッチングサービス
- メンタープログラムやe-learningなどを含むキャリア開発
- 女性の活躍を支援する社内キャリアネットワーク
- 自社株購入制度
- その他
- 通勤手当、勤務時間外手当、休日勤務手当
- 土曜日、日曜日、祝祭日
- 年次有給休暇、公傷病休暇、生理休暇、産前産後休暇
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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