• Comprehensive knowledge of FDA, ICH/GCP regulations for clinical research • Possess a wide range of qualitative and quantitative methods for management of clinical trials • Maintain a robust compliance culture for complex management processes, systems and accreditations • Govern financial controls and allocations/projections for research program • Develop and implement strategic risk-based assessment and audits • Produce a timely, efficient and effective outcome of the clinical trials • Formulate, implement and maintain GCP systems and govern clinical study program • Conduct internal audits of the clinical quality program to ensure safety • Create and revise local policy for compliance and strategic implementation • Plan, direct and develop administrative objectives of the healthcare facility’s R&D Service • Employ a collaborative and mentoring management style

Clinical Quality Manager @ From March 2015 to Present (10 months) Tampa/St. Petersburg, Florida AreaDirector, Administration @ From July 2014 to March 2015 (9 months) Tampa/St. Petersburg, Florida AreaVoting IRB Member @ From September 2013 to August 2014 (1 year) R&D Program Manager @ From September 2010 to August 2013 (3 years) Study Manager @ From 2008 to 2010 (2 years)

Doctor of Philosophy (Ph.D.), Epidemiology and Biostatistics @ University of South Florida From 2014 to 2018 Graduate Certificate in Applied Biostatistics (w/ SAS Programming), Public Health @ University of South Florida From 2013 to 2015 Master of Science (MS), Administration (Healthcare) @ University of West Florida From 2007 to 2008 Bachelor of Science, Biomedical Science @ University of South Florida Deborah Formelio, MSA is skilled in: GCP, Clinical Trials, CRO, FDA, Clinical Study Design, Protocol, Clinical Research, IRB, Healthcare, Clinical Development, Regulatory Affairs, Data Management, Pharmaceutical Industry, SOP, Life Sciences