Glaudio Garcia

My duty was to coordinate the relation with organizations, negotiate and influence representatives to develop joint projects based on strong analysis capabilities, and to propose strategies and collaboration plans.

Access to medicines and clinical research go hand-in-hand. As the former enhances, the latter boosts. Based on my experience, I evaluated the impact of the UE pharmaceutical regulatory framework.

- Project Management: control of the project budget, quality and scope. Supervision of the project risks and key project metrics. Development of the Monitoring Plan, CRFs and ICFs. - Site and investigator selection: evaluation of sites and investigators, site budget and contract negotiation. - Site Initiation activities: coordination of the site initiation activities, oversight of protocol procedures. - Implementation and follow-up of the protocol-related procedures.

Vendor management: active coordination of the various vendors, supervision of the study material delivery to each site and oversight of the fully and optimal functionality of the digital tools developed for the generation and collection of study data.

Experience in start-up, SEV, SIV, MV, CM, IM, COV, regulatory requirements and quality assurance. Phases II and III. Mentored and trained Jr. CRAs. Achievements: - Extension of long-term partnerships deals with 2 key accounts. - Zero (0) critical findings in sponsor-led audits. - Not a single monitoring report submitted late. Findings/issues resolved within 30 days in average. - Built functional relationships with the study sites and my teams. Efficient and productive site management

Clinical Research and clinical trials