Clinical Trials Trial

Lisa Daly, Senior TMFa

Durham, NC • **********@*****.*** • 908-***-****

PROFESSIONAL SUMMARY: Experienced and results-driven Trial Master File (TMF) Associate with over 10+ years of excellence in clinical trial documentation and regulatory compliance within the pharmaceutical and biotechnology sectors. Deeply specialized in supporting oncology, respiratory, and ophthalmology clinical trials, with a focus on biomarker tracking and data integrity. Proven ability to collaborate with cross-functional teams to ensure seamless trial execution. EDUCATION AND SKILLS

Avtech Institute of Technology, USA Microsoft Office Specialist (MOS) Skills: Clinical Trials and Research, Account Management, Confidentiality, Veeva Vault eTMF user, Master Control QMS user, SharePoint CRM user, Creates ISF Binders via Mimeo Printer user, Strong Communication, pays attention to detail. WORK EXPERIENCE

Senior Trial Master File Associate, TFS, USA January 2023-May 2025

● Therapeutic Area Expertise: Contributed to the execution of Phase I–IV clinical trials across oncology, respiratory, and ophthalmology therapeutic areas, with a strong focus on biomarker tracking and protocol adhesive.

● Job Responsibilities: Establishes and Maintains the TMF according to regulatory requirements and internal requirements and internal (SOPs). Reviews trial documents for completeness, accuracy, and compliance with regulatory requirements. Ensures that documents are filed and indexed correctly in the TMF. Facilitates TMF inspections and audits by regulatory authorities and sponsors.

● Process Optimization & Efficiency: Reduced TMF document backlog through implementation of streamlined workflows and targeted training sessions. Developed SOP updates for multiple teams, enhancing TMF health metrics.

● Cross-Functional Collaboration: Liaised with clinical operations, regulatory, and QA teams across global sites to resolve document discrepancies within SLA timeframes. Ensured timely upload and filing of essential documents, improving TMF completeness.

Trial Master File Associate, TFS, USA February 2020-January 2023

● TMF Lifecycle Management: Maintained compliance and audit-readiness for over 35 clinical studies by managing TMF documentation using industry-standard eTMF platforms. Improved document filing timelines through proactive reconciliation and QC reviews.

● Quality Compliance: Supported successful completion of 10+ sponsor and regulatory inspections (FDA, EMA) with zero major findings by ensuring documentation accuracy and real-time compliance with ICH-GCP guidelines.

● Data Quality & Metrics Reporting: Monitored TMF performance using KPIs and dashboards; generated monthly status reports that informed decision-making and improved sponsor satisfaction. Clinical Trial Associate, TFS, USA July 2015-February 2020

● Study Start-Up & Site Activation: Coordinated start-up activities for 15+ global Phase II–III clinical trials, accelerating site activation timelines through efficient collection and tracking of essential regulatory documents, investigator agreements, and IRB approvals.

● Document Management & Quality Control: Maintained accuracy in trial documentation by conducting regular QC reviews and reconciliation of study files in eTMF systems. Reduced document retrieval time by implementing an organized digital filing structure aligned with TMF Reference Model standards.

● Clinical Site Support & Communication: Acted as primary liaison for 25+ clinical sites, resolving of site queries within 48 hours. Facilitated timely CRF completion and query resolution, contributing to a reduction in data lock timelines across assigned studies.

Site Support Associate, LabCorp, USA May 2004-December 2014

● Site Communication & Coordination: Supported active clinical sites across multiple regions, achieving 95% SLA compliance for site query responses. Streamlined communication workflows, reducing average query resolution time.

● Regulatory Document Management: Tracked, collected, and verified essential documents ensuring 100% readiness for SIVs and site initiations. Decreased document turnaround time by using improved tracking systems.

● Training & Compliance Support: Coordinated onboarding for site staff members, ensuring completion of all protocol-specific training within project deadlines. Helped achieve training compliance rate during audits. References upon request

Contact this candidate