グローバルな環境で医薬品開発/Clinical Trial Manager/臨床開発モニター(CRA) 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2017年 08月 23日

求人情報

臨床開発モニター(CRA)

求人管理No.011471

会社概要

グローバルな環境で医薬品開発/Clinical Trial Manager

医薬品開発・製造・販売における上流から下流まで幅広く支援ができます。

募集要項

・Responsible for overall management of the study/ project assigned from start up through study close-out,
in compliance processes and regulatory requirements.
・Communicates with clients, regulators, CROs and other vendors to ensure the successful conduct of studies.
・Develop, review, and/or approve on Informed Consent Form (ICF), Case Report Form (CRF), Data
Management (“DM”), and documents used in the study in coordination with the Project Team
・Ensure project timelines and quality of deliverables required by the sponsor/ client are met
・Oversee of site feasibility and selection process
・Assist in regulatory document maintenance including document collection and submission to regulatory
authorities and Independent Ethics committee(IEC)/Institutional Review Board(IRB)
・Assist in Review labeling for compliance with regulatory requirements
・Assist in the Management of a process related the study drug including importation, returning to sponsor
or destruction
・Provide or facilitate training to clinical study teams on assigned protocol specific topics
・Mentoring CRA including training, communication with site staffs and monitoring activities, as necessary.
・Responsible for implementation and compliance to key contract provisions while informing management
and client for out of scope activities
・Communication and collaboration with the internal project team, clients, and vendors providing accurate
labor forecasts, reviewing pass-through costs and ensuring timely invoicing
・Assist in the management importation/ exportation and accountability of IP and Non-IP clinical materials
・Oversee site visit compliance and review site visit reports
・Perform co-monitoring visits with CRA as necessary
・Perform periodic review of issues to identify any trends for communicating and taking appropriate action

募集条件

  • ・大学卒以上
    ・5年以上の臨床開発実務経験
    ・GCP / ICHガイドラインと臨床開発プロセスの知識
    ・CTMの経験もしくは、リードCRA経験
    ・フェーズ1~3の臨床試験経験
    ・英語力

勤務開始日

  • 応相談

雇用形態

  • 正社員

勤務地

  • 東京

転勤有無

  • なし

給与

  • ご経験に応じての額となります。