Julia Coyle

Background

About Julia Coyle

Strategic and proactive Clinical Trial Manager with broad-spectrum experience from site to sponsor, including 6 years as a CRA and recent leadership of U.S. cross-functional teams on complex Phase 3 trials. Strong track record of planning and delivering study milestones from country planning through closeout—achieving enrollment targets under pressure while navigating diverse cultural and operational landscapes. Skilled in change management across systems, team structures, and workflows, maintaining quality and timelines. Technically adept and highly flexible, with a strong track record of embracing evolving digital tools, CTMS, and eTMF platforms. CORE COMPETENCIES Clinical Trial Management | Cross-functional Clinical Operations Leader | CRA Oversight | CRO Oversight | Vendor Oversight | Risk Mitigation | eTMF | Phase 2/3 Trials | stakeholder communication | Functional manager collaboration | Development and Compliance with Training and Monitoring Plans | Data monitoring / query resolution | internal and external meeting facilitation |Clinical Trial Supply Management |Monitoring Quality Assessment Visits |eCRF Guideline Development | Safety reporting | Investigator Payment Oversight | Clinical trial dashboards / CTMS reporting | Development of study tools/templates Local Study Team (LST) Leadership | Country Operational Planning | Enrollment Long-Range Estimates (ELE)| Clinical Study Reports (CSRs)| Matrixed Team Environment | Investigator Meeting Planning | Analytical and problem-solving skills | Cross-cultural / Global Collaboration | Change Management | Mentorship / Coaching THERAPEUTIC EXPERIENCE Cardiovascular Renal Metabolic (CVRM) – Hyperlipidemia, Cardiovascular Outcomes, Heart Failure, Hyperkalemia, Diabetic Kidney Disease | Women’s Healthcare – Vasomotor Symptoms | Endocrinology / Metabolic Disorders – Diabetes Mellitus Type 1 & 2| Central Nervous System (CNS)- Stroke | Organ Transplant – Islet Cell, Kidney | Vaccine – Pediatric Influenza