Angela Rhodes
Expert in Good Clinical Practice and Regulatory Compliance | Former FDA Investigator
- Role
- Quality Manager at 艾昆纬
- Location
- Melbourne, FL, US
- LinkedIn followers
- 500 followers
About Angela Rhodes
High-Impact Clinical Trials Director | Strategic Leadership in Biotech Accelerate your clinical trials with over two decades of dynamic leadership in the biotech realm. As a seasoned Clinical Trials Director, I bring unparalleled expertise in steering trial execution strategically, ensuring compliance with SOPs and ICH-GCP across diverse therapeutic areas. Key Strengths: Strategic Project Management: Adept at overseeing trial execution from a view, ensuring seamless integration of site management and monitoring activities at the CRO level. Leadership Excellence: Proven track record of training and managing Clinical Trial Managers and CRAs, fostering a culture of continuous improvement and team success. Regulatory Mastery: GCP expert (FDA, ICH, EMA), with a keen eye for compliance, conducting audits at vendors, CROs, and sponsors from both FDA and ICH GCP perspectives. Professional Journey: Director GxP Strategy/Consulting | Allucent/CATO SMS/CATO Research, Cary, NC | 2012 – 2023Spearheaded the creation of a department, achieving a forecasted income goal of in year one.Conducted audits at vendors, CROs, and sponsors from both FDA and ICH GCP perspectives. Director, Clinical Trial Operations | Allucent/CATO SMS/CATO Research, Cary, NC | 2020 – 2023Integral in departmental operations during acquisitions and subsequent integration.Played a key role in the establishment of Veeva CTMS, enhancing operational efficiency. Project Manager/Clinical Study Manager | Allucent/CATO SMS/CATO Research, Cary, NC | 2017 – 2019Led the development and implementation of a training program for 500 staff globally on risk-based monitoring. Clinical Site Manager | Melbourne Cardiac Research Institute, Melbourne, FL | 2010 – 2012Established clinical research operations for ten cardiologists, overseeing 10 studies enrolling more than 200 participants. Consumer Safety Office/Investigator | U.S. Food and Drug Administration, Atlanta, GA - Boca Raton, FL | 1990 – public health and safety through inspections and investigations across FDA-regulated industries.Collaborated closely with criminal investigation units, participated in stakeouts, and provided grand jury testimony. Passionate about Transforming Biotech:Thriving in the dynamic landscape of small to mid-size biotech companies, I am dedicated to driving excellence in clinical trial operations. Ready to Transform Your Clinical Trials? Let\'s Connect! r••••••••@gmail.com
Experience
Quality Manager
Jan 2024 — Present
Portfolio-level CAPA governance lead for significant quality issues and audit/inspection responses; review/approve investigations, RCA, CAPA and effectiveness checks. Investigation of quality issues across all pillars. Cross functional global knowledge of processes and procedures across pillars. Utilizes Artificial Intelligence (Agents, ChaptGPT, CoPilot) in an advanced manner for efficiencies and work product quality.
Education
University of North Georgia
Bachelor's degree, Biology and Chemistry
University of North Georgia
Bachelor's degree, Biology/Chemistry
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