Latanya Andrews

About Latanya Andrews

Clinical Research Professional • 20+ Years • Pharma | Biotech | Med Device | Vaccines | Clinical I’m a results-driven Clinical Trial Project Manager and TMF Lead with a proven track record across Phase I–IV studies, including Oncology, Rare Disease, Observational Studies, and Expanded Patient Access programs. I specialize in: ‍Regulatory Compliance & Quality Assurance – Expert in ICH E6(R3), GCP, FDA/EMA submissions, and audit remediation. Trial Master File (TMF) Management – Achieved > 90% inspection-ready TMF metrics by implementing process automation and best-practice SOPs. Site Start-Up & Operations – Led site selection, initiation, and monitoring across 50+ global sites, accelerating time-to-first-patient by 25%. Project & Budget Management – Delivered 20 – 30% cost savings via resource optimization, vendor negotiations, and real-time analytics dashboards (Power BI/Veeva Vault). Clinical Trial Management | Project Leadership | TMF/eTMF | Regulatory Submissions | ICH E6(R3)| FDA/EMA | Quality Systems | Risk-Based Monitoring | Cross-Functional Teams | Vendor Management | Budget Negotiation | Process Improvement | Root Cause Analysis | Stakeholder Engagement Data Integrity | Audit Readiness | Protocol Development | eRegulatory Systems Career Aspiration I aim to leverage my deep clinical operations expertise to become a visionary Director of Clinical Compliance & Efficiency, driving end-to-end trial excellence and accelerating life-changing therapies to patients. Let’s Connect If you’re seeking a seasoned leader who can elevate your clinical programs, optimize TMF processes, and ensure regulatory success, let’s talk.

Experience

1. Real Estate Agent

   Virtual Properties Realty

   Jan 2023 — Present · Atlanta, GA, US

Education

• Rutgers University

  Master of Science - MS

  2023 — 2025

• Community College of Philadelphia

  Paralegal Studies

• Lincoln Tech

  Pharmacy Technician/Assistant

• Saint Joseph's University

  Bachelor’s Degree