Lori Fiedler

Served as eTMF SME supporting global clinical studies in Veeva Vault eTMF. Provided governance and oversight of TMF activities ensuring compliance with ICH-GCP, DIA TMF Reference Model, and company standards. Performed QC of essential clinical trial documents to maintain inspection-ready TMFs. Supported Clinical Operations, Regulatory Affairs, Pharmacovigilance, and vendors with filing, reconciliation, and TMF quality oversight. Provided end-user support, troubleshooting, and guidance on TMF filing, classification, and system use. Supported TMF metrics, issue tracking, reconciliation, and archival activities. Participated in UAT testing and system validation for enhancements and process improvements.

Managed paper and electronic TMFs across Phase II and III global clinical studies from study startup through closeout. Conducted quality review and reconciliation of TMF content to ensure completeness, accuracy, and inspection readiness. Partnered with Clinical Operations, Regulatory Affairs and Pharmacovigilance to support consistent document management practices across studies. Developed, maintained, and updated TMF-related SOPs, work instructions, and process documentation. Conducted TMF training and onboarding sessions for study teams and functional stakeholders. Evaluated TMF management practices and recommended process improvements to enhance quality and compliance. Supported audits, inspections, TMF health checks, and study closeout activities including archival preparation.

Supported collection, review, and quality control of study documents across eTMF and CRO systems. Maintained study trackers and communication tools to ensure up-to-date documentation and accurate study status reporting. Provided operational support to project leads, including document coordination and study team communications. Assisted with study metrics, tracking, and reconciliation activities to support compliance and inspection readiness

Reviewed active and archived TMFs for compliance with DIA TMF Reference Model and regulatory requirements. Performed QC review and reconciliation activities across paper and electronic TMF systems. Identified documentation gaps and worked with study teams to drive issue resolution and improve inspection readiness.

Managed filing, indexing, maintenance, and reconciliation of paper and electronic TMF documentation. Supported study teams by ensuring accurate and timely filing of essential documents in accordance with sponsor and regulatory requirements. Contributed to inspection readiness through ongoing TMF quality reviews and document tracking activities.

Supported preparation, review, filing, and maintenance of essential clinical trial documentation for global studies. Collaborated with Clinical Operations, sites, and vendors to resolve documentation issues and maintain compliant TMFs. Assisted with TMF quality reviews, audit support, and inspection readiness initiatives.

Completed coursework toward an Associate’s Degree