Roxana Alvarez

Background

About Roxana Alvarez

Senior Clinical Research Professional with over 28 years of experience in international, multicentre, Phase I to IV clinical trial studies and programs in various indications, working in Multi-National Pharmaceutical Companies and CROs across all regions. Experience managing studies and leading teams for biotechnology companies as well as larger pharmaceutical companies. Adept at conducting studies from start-up to closure, driving internal/external audits from preparation to reports finalization, inspections for phase I-IV studies. Conducted clinical trials from feasibility, site selection and qualification phase focusing on site and remote monitoring oversight, implementing data-driven monitoring strategy, and data management plans using different EDC platforms. Risk identification and mitigation. Compliance with national and international regulations, ICH-GCP & EU Directives. Experience on SOP development. Serving as Subject Matter Expert for new systems and new company’s initiatives. Trainer, coach and mentor for new-hired employees and employee’s career path development. Areas of strength include (but are not limited to): strong communication and leadership skills, leading teams, effectively communicating with internal and external customers as well as third party vendors. Problem-solving attitude. Efficiency and forward planning. Working to lead the teams to meet the planned goals and timelines. Strategic thinking and planning. Technology oriented and early-adopter. Processes-oriented.