eTMF Specialist

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

The successful candidate will work closely with Clinical Project Managers, Clinical Trial Associates, Clinical Operations teams, and CRO partners to ensure TMFs remain complete, compliant, and inspection-ready throughout the study lifecycle.

Key Responsibilities:

• Manage and maintain TMF/eTMF documentation throughout the entire clinical trial lifecycle, from start-up to archiving.
• Ensure TMF completeness, quality, accuracy, and inspection readiness at all times.
• Conduct TMF quality reviews, reconciliation activities, and completeness assessments.
• Track, follow up, and resolve missing, incomplete, or overdue study documents.
• Monitor and report TMF health, quality, and compliance metrics.
• Collaborate closely with Clinical Project Managers, Clinical Operations teams, CTAs, and CRO partners.
• Provide guidance on TMF requirements, filing standards, documentation practices, and compliance expectations.
• Manage daily activities within Veeva Vault eTMF, including document filing, classification, and metadata management.
• Serve as a Subject Matter Expert (SME) for eTMF processes and Veeva Vault, while supporting process improvements and system enhancements.
• Ensure compliance with ICH-GCP, regulatory requirements, and SOPs, support audits and inspections, contribute to remediation plans, and deliver TMF-related training and best practices to study teams and CROs.