[Janssen] Contract & Compliance Services, Site Engagement Analyst

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募集要項

会社概要

同社は、世界的な製薬企業の一部であり、医療・健康分野に特化した製品とサービスを提供しています。主に医薬品の研究開発、製造、販売を行い、疾病の治療や予防に貢献しています。革新的な医療技術と科学的アプローチに基づき、高度な研究と開発を進め、新たな治療法や医薬品を市場に提供しています。また、医療従事者や患者への教育活動や支援プログラムも展開し、医療の質の向上に寄与しています。グローバルに展開するネットワークを活かし、多様な地域と市場でのニーズに応え、持続可能な医療イノベーションを推進しています。

業務内容

• Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations.
• Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
• Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
• Manage the contract amendment lifecycle.
• Assume responsibility for all aspects of legal document and metrics tracking.
• Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
• Comply with requests from QA and auditors.
• Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
• Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate.
• Exemplary customer focus with vision to drive solutions

応募条件

• CRA experiences
• Able to take English Interview

給与

600 - 900 万円

勤務地

東京