Lori Fiedler

Senior Clinical Trial and TMF professional with 10+ years of experience supporting global clinical studies within pharmaceutical, biotech, and CRO environments. Extensive expertise in clinical trial documentation, eTMF management, inspection readiness, quality control, study tracking, and cross-functional study support. Proven ability to independently manage multiple competing priorities in fast-paced clinical operations environments while ensuring compliance with ICH-GCP, regulatory standards, and SOP requirements.

Experienced collaborating with Clinical Operations, study teams, CROs, vendors, Legal, QA, and regulatory functions to support successful study execution and audit readiness.

TMF Specialist - Hays – Contracted to Prothena - Remote

(2023-01 - 2025-06)

• Independently performed ongoing QC review of essential clinical trial documents within Veeva Vault eTMF to support inspection readiness and regulatory compliance.
• Conducted TMF completeness reviews, reconciliation activities, and issue tracking across multiple global studies.
• Collaborated with Clinical Operations teams, study teams, and functional stakeholders to resolve documentation discrepancies and maintain audit-ready TMFs.
• Supported study execution activities by maintaining accurate documentation workflows and reporting metrics.
• Participated in UAT testing and validation activities for system enhancements and configuration changes.
• Supported multiple concurrent studies while meeting strict timelines and compliance requirements.

TMF Specialist - PhaseBio Pharmaceuticals - Malvern, PA

(2020-10 - 2023-01)

• Managed paper and electronic TMF activities across multiple Phase 2 and Phase 3 global clinical studies.
• Reviewed essential study documentation including regulatory packets, study records, and trial documentation for completeness and compliance.
• Supported inspection readiness activities including TMF reconciliation, audit support, and preparation of study materials.
• Collaborated cross-functionally with Clinical Operations, CROs, vendors, and internal departments to support study milestones and timelines.
• Assisted with study close-out activities including document reconciliation and final TMF reviews.
• Developed and enhanced TMF QC review processes and provided training support to new staff members.
• Participated in eTMF system UAT activities and workflow improvement initiatives.

Clinical Trial Associate - Redbock – Contracted to Esperion - Remote

(2018-01 - 2020-06)

• Supported day-to-day clinical trial operations and study documentation activities across global clinical studies.
• Maintained study tracking tools, logs, and communication reports to support operational oversight and study timelines.
• Collaborated with CROs, vendors, and study teams to support collection, review, and reconciliation of essential study documentation.
• Assisted with inspection readiness efforts through QC review, documentation tracking, and issue resolution activities.
• Supported study metrics reporting and operational follow-up activities.

Clinical Trial Associate - ExecuPharm – Contracted to Pfizer - Remote

(2017-10 - 2017-12)

• Reviewed active and archived TMFs for compliance with DIA TMF Reference Model and regulatory standards.
• Performed reconciliation and QC review activities across eTMF, paper, and CRO systems.
• Identified documentation gaps and collaborated with study teams to support timely resolution and inspection readiness.
• Supported tracking and follow-up of corrective action items and study documentation issues.

Documentalist - PSI CRO - King of Prussia, PA

(2016-01 - 2017-10)

• Managed filing, organization, and maintenance of paper and electronic TMF documentation in support of global clinical studies.
• Maintained study tracking systems and collaborated with study teams to ensure TMF completeness and compliance.
• Supported timelines and inspection readiness through ongoing documentation review and reconciliation activities.

Clinical Trial Associate - Shire (formerly ViroPharma) - Exton, PA

(2010-09 - 2015-04)

• Supported preparation, review, filing, and maintenance of essential clinical trial documentation for global studies.
• Coordinated with Clinical Operations, sites, and vendors to resolve documentation issues and support study execution.
• Assisted with inspection readiness activities, TMF QC review, and audit support.
• Participated in UAT activities for document management system enhancements.

Quality Assurance Coordinator - Shire (formerly ViroPharma) - Exton, PA

(2010-03 - 2010-09)

• Supported SOP lifecycle management and maintained training compliance systems.
• Coordinated QA documentation activities supporting GMP and regulatory compliance initiatives.
• Maintained controlled documentation systems and supported inspection readiness activities.

Records Management Analyst / Information Specialist / Regulatory Affairs Operations Associate - Johnson & Johnson – Centocor R&D - Malvern, PA

(1999-01 - 2009-12)

• Supported regulatory operations, records management, SOP maintenance, inspection readiness, and archival activities within regulated pharmaceutical environments.
• Managed clinical and regulatory documentation supporting audits, inspections, litigation support, and compliance initiatives.
• Collaborated with cross-functional departments to ensure accurate records management and regulatory compliance.

Credits Toward Degree - Western Montgomery County Community College

Certificate - Data/Word Processing - Western Vocational Technical Center