Lauren White
Senior TMF Specialist | Sponsor-Side Oncology (Multi-IMP Combination Trials) | TMF Oversight | Remediation & Inspection Readiness | GCP | 21 CFR Part 312
- Role
- Sr Manager Tmf at Abivax
- Location
- Charleston, SC, US
- LinkedIn followers
- 500 followers
About Lauren White
Sr. Trial Master File (TMF) Specialist with TMF Mastery Certification & sponsor-side experience supporting oncology clinical trials. Brings prior (sponsor) FDA inspection experience, including active participation in inspection war room activities, supporting real-time document retrieval, TMF readiness, and response coordination. Provide sponsor oversight of CRO vendors, performing milestone-based, risk-proportionate TMF gap analysis aligned with ICH E6(R3) for Phase I-IV studies. Aptitude to prioritize and plan based on importance, meet goals and aggressive deadlines under pressure, in a fast-paced environment while maintaining quality results. eTMF Systems (Veeva Vault, Wingspan, Trial Interactive, Medidata eTMF)
Experience
Sr Manager Tmf
Mar 2026 — Present · US
Education
Trident Technical College
Associate's degree
Skills
- Adaptability
- Salesforce
- Pharmaceutical Industry
- Accounts Payable
- Document Management
- Collaborative Institutional Training Initiative (Citi)
- Microsoft Excel
- Regulatory Documentation
- Microsoft Office
- Sales
- Regulatory Policy
- Clinical Development
- Medidata
- Customer Service
- File Archiving
- Trial Master File (Tmf)
- Cross-Team Collaboration
- Clinical Trials
- Clinical Trial Management System (Ctms)
- Quickbooks
- Data Validation
- Research
- Investigator Payment Specialist
- Wingspan
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