Roberta Xavier Email & Phone Number | Pharmacist with more than 10 years of experience in the clinical research mainly in oncology studies conducted in Pharmaceutical industry and CRO. Broad knowledge of ICH/GCP, local and global regulation in clinical trials participating in more than twenty Phase 2 and Phase 3 studies (including COVID-19 vaccine study) in several different roles such as Clinical Quality Associate Director, Clinical Quality Manager, Local Study Manager, Global Site Management and Monitoring Lead, Local Study Lead and Clinical Research Associate. As Clinical Quality Associate Director and Clinical Quality Manager is experienced in development, implementation and management of Clinical Procedures, providing support and training and conduction of quality control activities working within different areas to identify potential gaps and implement improvements in order to have more efficiency and efficacy assuring the quality of the end-to-end clinical trial process. Experienced in quality issue and risks identification, CAPA development, quality visits conduction and preparation for Audits and Inspections. As Global Lead was responsible together with Global Study Team for supporting and oversight KPIs and the effective delivery of 23 countries in both initial and end study phases.

Roberta Xavier

Pharmacist with more than 10 years of experience in the clinical research mainly in oncology studies...
São Paulo, São Paulo, Brazil

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Roberta Xavier’s Location São Paulo, São Paulo, Brazil

Roberta Xavier’s Current Industry Astrazeneca

Roberta Xavier’s Prior Industry Astrazeneca Do Brasil | Ppd | Supernova

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Clinical Quality Associate Director

2021-10-01 00:00:00 - Present

Clinical Research Associate II

2014-09-01 00:00:00 - 2017-04-01 00:00:00

Clinical Research Associate

2013-02-01 00:00:00 - 2014-09-01 00:00:00

Translator and Reviewer

2006-06-01 00:00:00 - 2010-07-01 00:00:00

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Roberta Xavier is a Pharmacist with more than 10 years of experience in the clinical research mainly in oncology studies conducted in Pharmaceutical industry and CRO. Broad knowledge of ICH/GCP, local and global regulation in clinical trials participating in more than twenty Phase 2 and Phase 3 studies (including COVID-19 vaccine study) in several different roles such as Clinical Quality Associate Director, Clinical Quality Manager, Local Study Manager, Global Site Management and Monitoring Lead, Local Study Lead and Clinical Research Associate. As Clinical Quality Associate Director and Clinical Quality Manager is experienced in development, implementation and management of Clinical Procedures, providing support and training and conduction of quality control activities working within different areas to identify potential gaps and implement improvements in order to have more efficiency and efficacy assuring the quality of the end-to-end clinical trial process. Experienced in quality issue and risks identification, CAPA development, quality visits conduction and preparation for Audits and Inspections. As Global Lead was responsible together with Global Study Team for supporting and oversight KPIs and the effective delivery of 23 countries in both initial and end study phases.