Amber Dunham Eruchalu
Principal Clinical Research Specialist @美敦力
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WORK HISTORY
Principal Clinical Research Specialist @美敦力
Lafayette, CO, US
Lead post-market clinical follow-up (PMCF) initiatives across the Gastrointestinal and Hepatology franchises, ensuring regulatory compliance (EU MDR) and clinical excellence.Key Achievements & Responsibilities:• Managed a large clinical study, managing budgets, and site closeouts while delivering 100% of enrollment targets ahead of schedule.• Evaluated and authored Clinical Evaluation Reports (CER) and Post Market Clinical Follow Up (PMCF) plans, in compliance with European Union Medical Device Regulations (EUMDR), establishing a framework for ongoing evidence generation.• Partnered with cross-functions (e.g Research and Development, Regulatory Affairs, and Marketing) to align clinical data with business and product goals.• Developed data-tracking and reporting processes to improve transparency and decision-making.• Served as Clinical Quality liaison during internal audits—resulting in zero findings and strengthening organizational compliance.• Managed team performance reviews, mentoring staff toward professional growth.• Recognized for cross-functional leadership, collaboration, and contributions to decisions related to funding and supporting Investigator Initiated Research Studies.
EDUCATION
University of Hartford
Master of Science (M.S.), Neuroscience
Marquette Senior High School
General Studies
Grand Valley State University
BS, Psychology
SKILLS
ABOUT AMBER DUNHAM ERUCHALU
I’m a results-driven healthcare professional with a passion for using data, collaboration, and human-centered thinking to improve medical technologies and patient outcomes.Currently a Principal Clinical Research Specialist at Medtronic, I bring 15+ years of experience spanning clinical research management, education, systems development, and regulatory strategy. My career has centered on connecting the dots between clinical evidence, user experience, and strategic innovation — ensuring that products not only meet compliance standards but also align with real-world needs.In recent years, I’ve expanded my scope to include data analytics and digital transformation initiatives. From managing post-market clinical evidence to developing learning systems and leading multidisciplinary teams, I thrive at the intersection of technical insight and people leadership.I’m now exploring opportunities to apply my background in clinical data, process optimization, and human factors toward forward-looking roles — whether in data science, product insights, or research strategy — where I can help translate complex information into actionable outcomes for patients, clinicians, and business partners.Interests: Data Science, Human Factors & User-Centered Research Core Strengths:Clinical Research Leadership & Data AnalysisProcess Optimization & Systems ImplementationCross-Functional Collaboration & Stakeholder EngagementStrategic Thinking & Continuous ImprovementTraining, Mentorship, and Organizational DevelopmentContact me at: a••••••••@gmail.com
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