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Trenton

    Regulatory Document Management Lead - Trenton, United States - Network Partners Group

    Network Partners Group
    Network Partners Group Trenton, United States

    2 weeks ago

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    Description

    Position Overview:
    We are seeking a highly skilled and experienced ETMS Expert to join our team.

    The ETMS Expert will play a critical role in overseeing the implementation, maintenance, and optimization of our Electronic Trial Master File System.

    This individual will collaborate with cross-functional teams to ensure compliance with regulatory requirements, streamline processes, and enhance the efficiency of clinical trial operations.


    Key Responsibilities:
    Serve as the subject matter expert on the Electronic Trial Master File System, including configuration, customization, and user support.

    Lead the implementation and validation of ETMS software, ensuring alignment with regulatory guidelines (e.g., FDA, EMA, ICH).Develop and maintain ETMS user training materials and provide training to internal stakeholders as needed.

    Collaborate with Clinical Operations, Data Management, and Quality Assurance teams to ensure data integrity, completeness, and compliance with SOPs.
    Proactively identify areas for process improvement and drive initiatives to enhance the efficiency and effectiveness of ETMS workflows.
    Stay current with industry trends and best practices related to electronic document management systems and regulatory requirements.
    Participate in audits and inspections related to ETMS, providing support and documentation as needed.
    Serve as a point of contact for ETMS vendors, managing relationships and troubleshooting technical issues.#J-18808-Ljbffr

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