Lisa (Speed) Martin

• Head of Internal QA and set CRO-wide global quality strategy and priorities. • Lead inspection readiness, gap assessments and corrective actions. • Direct service provider qualification and ongoing oversight program. • Implement ICH E6(R3) quality framework across SOPs and processes. • Oversee Part 11/Annex 11 system validation and secure e-signature tools. • Ensure eTMF/Veeva QC aligns with DIA standards. • Chair Controlled Document Committee • Member, Data Privacy committees. • Manage, coach, and develop a first-class QA team. • Lead global team to conduct internal, site, and service provider audits; CAPAs management. • Host customer audits and support regulatory inspections.

• Serve on the program advisory committee. • Curriculum Development and Course Design • Teach courses in clinical research foundations, regulatory compliance, trial operations, pharmacology, research management, leadership, data management, and research design.

• Led the Clinical QA function. • Qualified 18 GxP vendors and closed 47 findings. • Developed project-level quality management plans. • Investigated emerging compliance issues and trends. • Reviewed and approved standard operating procedures. • Managed QA contractors to ensure efficient, collaborative operations.

Achieved five promotions over nine years, advancing to roles with increasing responsibilities in quality assurance activities. • Hosted regulatory inspections and sponsor audits. • Investigated compliance issues and potential misconduct. • Directed activities for the Site Audit Team. • Led hybrid trial designs incorporating eConsent, telemedicine, and home visits for three COVID studies. • Piloted a tele-monitoring model during COVID, achieving 90% completion of monitoring visits.

• Built and maintained a complete quality management system for a network of 10 Investigator sites. • Supported sponsor audits and inspections at the site level. • Conducted site risk assessments. • Oversaw COVID-related protocol and site procedure adjustments.

• Lead Kaizen/Lean Sigma process improvement workshops and activities • Drive integrations, mergers and key process changes

• Conducted approx. 100 site risk assessments providing site process feedback • Served as QA partner to assigned sponsor companies

• Perform site selection, initiation, monitoring and close-out visits, maintaining 100% on-time reporting.

• Managed site operations, ensuring protocol compliance and patient care • Led teams, hiring, mentoring, and managing budgets • Oversaw facilities, vendors, and sponsors • Drove Sponsor relationships and study acquisition

• Supervised 12 CRAs; assigned visits, tracked KPIs, reviewed reports • Implemented monitoring tools and RBM dashboards • Provided real-time coaching and monthly performance reviews • Conducted real-time coaching and bi-weekly performance reviews.

• Led clinical research training for 1600+ staff across 11 countries • Created CRA and PM training programs • Implemented company-wide LMS

• Conducted internal audits on studies, documents, and validation • Performed external audits of vendors and sites • Peer review of audit reports

• Conducted internal audits on study processes • Managed regulatory document collection and IRB/EC approvals for multi-site projects

• Conducted site visits (initiation to close-out) to ensure protocol and regulatory compliance.

• Directed CRA activities, provided CRA field training and peer review of reports • Conducted site visits (initiation to close-out) to ensure protocol and regulatory compliance.

Various positions including university and private practice, Performed all site tasks related to clinical trial execution.

Magna cum laude