[Janssen] Contract & Compliance Services, Site Engagement Analyst

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募集要項

会社概要

同社はグローバル製薬会社です。

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