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    Regulatory Document Management Lead - New Jersey, United States - Network Partners Group

    Network Partners Group
    Network Partners Group New Jersey, 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.


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