Linda Hopkinson
Clinical Research Professional Working for my own Ltd Company @Integrity Clinical Compliance
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WORK HISTORY
Clinical Research Professional Working for my own Ltd Company @Integrity Clinical Compliance
I’ve been fortunate to work with an incredible range of companies as a freelance clinical research prodessional — from Bayer and Roche to GSK, MRN, Redx and many exciting biotech and CRO partners. My freelance projects cover everything from clinical monitoring and consultancy to medical writing, project management and quality assurance. I’m also proud to co-own Integrity Clinical Research ( formally training online 4u) where we offer global e-learning courses along with face 2 face/webinars and compliance support focused on clinical research, education, and personal development.
EDUCATION
Salford School of Nursing Salford NHS Trust
Registered General Nurse, Registered Nursing/Registered Nurse
SKILLS
ABOUT LINDA HOPKINSON
I am an experienced Quality and Regulatory Consultant with 35+ years of leadership across clinical research, quality assurance, regulatory compliance, and project management. I specialise in helping organisations strengthen quality systems, achieve inspection readiness, and navigate complex regulatory landscapes across multiple therapeutic areas.My career spans senior roles supporting end-to-end clinical development and GxP compliance, where I have delivered strategic QA oversight, operational improvements, and hands-on training to teams at all levels. I have led audits, developed quality frameworks, managed cross-functional projects, and supported organisations through MHRA, FDA, and EMA expectations.I bring a practical, solutions-driven approach, balancing regulatory rigor with operational efficiency to help organisations improve processes, reduce risk, and deliver high-quality outcomes.Core Expertise:• Quality Assurance (GCP/GxP)• Clinical Research Oversight• Regulatory Compliance & Inspection Readiness• QA Auditing (Vendor, Site, System, Process)• SOP Development & Process Optimization• Project & Program Management• Training & Mentorship• Risk Management & CAPA Leadership• Consultancy Across Pharma, Biotech & CROsOpen to new opportunities in quality, regulatory, consultancy, or leadership roles where I can support organisations in strengthening compliance, improving quality culture, and achieving operational excellence.
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