sr. clinical trial manager / 再生医療企業. Job at Randstad, 東京23区

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  • Randstad
  • 東京23区

Job Description

社名
社名非公開

職種
臨床開発、CRA、CRC

業務内容
再生医療に大変強みを持つバイオ医薬品会社
再生医療の技術を学べる環境

求められる経験
・Project Lead/Project Managementの経験 5年以上
(開発戦略の立案支援、開発戦略に基づいたClinical Development Planの作成、KOL対応の経験、PMDA meetingの経験)
・CRAの経験かつClinical Trial Manager (CTM)の経験  5年以上
(CRAとしては施設選定調査から試験実施施設の立ち上げ、症例登録
、SDV、施設クローズまでの一連の経験は必須、CTMとしては、治験届の作成/提出、治験薬概要書、治験実施計画書、同意説明文書の作成・改訂に携わった経験、ベンダー管理経験)
・製薬会社の臨床開発部門での業務経験 5年以上
・製薬会社におけるCROのマネジメント経験 2試験以上
・PMDAのGCP実地調査/書面適合性調査の実務担当者としての経験 2プロジェクト以上
・機構相談資料、治験総括報告書、CTD作成の経験 1プロジェクト以上

保険
健康保険 厚生年金保険 雇用保険

休日休暇
土曜日 日曜日 祝日

給与
年収850 ~ 1,400万円

賞与
-
雇用期間
期間の定めなし

Job Tags

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