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