Lauren Bolger

About Lauren Bolger

I am a Manager of Regulatory & Start-Up at IQVIA with over 10 years of experience in clinical trial management and regulatory compliance. Leading a team of 16 specialists, I excel in site activation, data management, clinical trial operations, and process improvement. Notable achievements include establishing key client partnerships, developing automated reporting tools, and managing resourcing over 100 trials across sites efficiently. I am passionate about optimizing clinical trial operations and driving regulatory excellence.

Experience

1. Manager, Regulatory & Start-up

   IQVIA

   Dec 2022 — Present · Raleigh-Durham-Chapel Hill, NC, US

   Oversee site activation managers, regulatory and start-up specialists, and contract negotiators to ensure site activations, study conduct, database locks, and final closeouts are completed ahead of schedule.• Collaborated with global trial teams to drive over 700 site activations over 2 years, reducing cycle times and improving metrics for site selection, site activation, protocol amendment approval, database lock, inspection readiness, and TMF/ISF completion. • Collaborate with FSP Leadership, clients, clinical teams, vendor managers, and the quality team to oversee, lead, and ensure inspection readiness, timely quality investigations, CAPA, and operational audit completion.• Serve as direct line manager for up to 28 FSP employees; contributed to a 134% headcount increase and 1.5% voluntary attrition rate — the lowest attrition in division history for the North America FSP RSU team.• Direct weekly client and operational oversight calls; serve as account manager for two clients; compile, analyze, and distribute KPI and milestone data, proactively driving improvements, identifying risks, and proactively implementing resolutions.• Received IQVIA IMPACT Awards for innovation, collaboration, and operational excellence.

Education

• The University of North Carolina at Chapel Hill

  Bachelor of Science (B.S.), Biology, General

  2007 — 2011

Skills

• Vital Signs
• Medicine
• Evidence-Based Medicine
• R
• Irb
• Home Care
• Hospitals
• Critical Care
• Statistical Data Analysis
• Medical Writing
• Microsoft Excel
• Biostatistics
• Shock
• Gcp
• Cardiology
• Data Analysis
• Tissue Processing
• Clinical Research
• Ebm
• Cna I
• Typescript
• Leadership
• Python
• Javascript
• Microsoft Office
• Healthcare
• Qualtrics
• Microsoft Powerpoint
• Emergency Medicine
• Informed Consent
• Research
• Surgery
• Infrared Thermal Imaging
• Project Management
• Epic Systems
• Jupyter
• Emr
• Databases
• Quality Improvement
• Patient Recruitment