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Clinical Research Manager（Line Manager）

年収：1000万 ～ 1500万

採用企業案件

特集求人

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ノボノルディスクファーマ株式会社

ノボノルディスクファーマ株式会社

  • 東京都

    • 資本金2,104百万円
    • 会社規模501-5000人
  • 医薬品メーカー
  • 医療機器メーカー
部署・役職名 Clinical Research Manager（Line Manager）
職種
業種
勤務地
仕事内容 About the Department
Clinical Operations Department provides timely, accurate and updated scientific expertise to drive business services in all therapeutic areas. Our working environment is characterized by interesting and demanding assignments and continuous professional development opportunities. The position Clinical Research Manager is to be located at Tokyo in Japan, and report to the Clinical Operations Senior Director.

The Position
Clinical Research Manager (CRM) works as the line manager for clinical research staff including Clinical Research Associate (CRA) and/or Trial Manager (TM) to ensure the implementation of clinical trials from job of site selection, application to Institutional Review Board (IRB), delivery of clinical supplies, monitoring, Source Document Verification(SDV), collecting Case Report Form (CRF) / Data Collection Form (DCF), drug accountability and site closure in compliance with Good Clinical Practice (GCP) and Standard Operation Procedure (SOP) and other regulations. CRM also works a Senior Trial Manager role, aims to have an efficient and seamless clinical development without compromising the quality as a clinical leader of the project development team. CRM selects suitable investigators/institutions for a project and conducts the trials according to the plan. In addition, CRM assists TM/CRAs in supervising high-quality monitoring activity (recruiting, monitoring, CRF&DCF/Monitor Initiated Data Reconciliation Form (MIDF) collection, etc.) according to GCP/SOP as well as accountable for preparing Trial Master File (TMF), manages/updates it to assure the quality of clinical data and submits notification to the government and pharmaceuticals and medical device agency (PMDA) in the suitable time.

Key tasks include, but are not limited to:
・Manage the team member. Ensure the On-the-Job Training (OJT) training of team members (CRA or TM) to improve and keep quality (the job of site selection, application to IRB, delivery of clinical supplies, monitoring, SDV, collecting CRFs, clean-up CRFs, drug accountability and termination application in compliance with GCP/SOP and other regulations.)
・Organize and lead a study team appropriately and work with project team to create the plans of the new project development such as strategy planning, Clinical Development Planning (CDP) preparation, etc. Design protocol based on the Trial outline (TO) and translate protocol into Japanese. Make operation plans (including a patient enrolment plan, CRF collection plan and a monitoring guideline) with other CRMs.
・Manage the study team members and relevant staff to prepare a clinical trial, conduct a clinical trial, collect data, and perform QC check on schedule. Approve labels for IMP and assist CRAs for monitoring activity (recruiting, monitoring, CRF&DCF collection, etc.) according to GCP and SOP.
・Find the cause of delay and its solution if a schedule is behind and give advice and instruction to concerned staff. Together with data management and statistics analysis to create the Clinical Trial Report (CTR). Prepare TMF and update it to secure the quality of the document.
・Cope with the internal Audit, GCP inspection and paper review sufficiently with other CRMs. Estimate and draw up the clinical budget (as accurately as possible) with Regional Project Lead and other CRMs based upon the planned trials. Submit notification to the government or PMDA in the suitable time.
応募資格

【必須（MUST）】

Qualifications
・Minimum of 10 years of experience in clinical operations, working on GCP clinical trials as CRA or TM.
・Experience in entire Clinical Trial Process (from Site selection to Trial Closure).
・Communicational level English (speaking and writing) and native level Japanese are required.
・Communication/Presentation skill for smooth communication with global, Study team, CRAs and TMs.
・Already showing Leadership to CRAs/Trial Managers/Study Team, people management experience is preferred.

アピールポイント 自社サービス・製品あり 外資系企業 女性管理職実績あり 従業員数1000人以上 創立30年以上 産休・育休取得実績あり ストックオプション制度あり 教育・研修制度充実
受動喫煙対策

屋内禁煙
更新日 2023/07/27
求人番号 2670301

採用企業情報

ノボノルディスクファーマ株式会社
  • ノボノルディスクファーマ株式会社

  • 東京都

    • 資本金2,104百万円
    • 会社規模501-5000人
  • 医薬品メーカー
  • 医療機器メーカー

  • 会社概要

    We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

    ノボノルディスクでは、これまで考えてきた「世界で最高の企業」になろうとするだけでは不十分であり、「世界にとって最高の企業」になろうとすることが必要だと考えています。そしてそれは様々な視点、経歴、文化を持った有能な社員がいてこそ、成し遂げることができます。私たちはそのために、社員、患者様やコミュニティにおける多様性（ダイバーシティ）を祝福するインクルーシブな企業文化を作ることにコミットしています。

    私たちはインクルーシブな採用プロセスと、全ての求人応募者様へ公平な機会を提供することにコミットしています。ポジションの役割とビジネスニーズにもよりますが、柔軟な働き方についても、喜んでご相談をお受けします。

    【設立】1980年6月20日
    【代表者】キャスパー ブッカ マイルヴァン
    【資本金】21億405万円
    【売上高】1,196億円 (2022年日本法人決算ベース)
    【従業員数】1,135名 (2023年12月末時点)
    【本社所在地】東京都千代田区丸の内2-1-1
    【その他事業所】宮城・愛知・埼玉・大阪・広島・福岡

    【事業内容】
    医療用医薬品、医療機器の開発、輸入・製造、販売（インスリン、GLP-1、成長ホルモン、 血液凝固因子製剤、それらの投与に必要な注入器や注射針）

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