Ludmila Matai Xavier Email & Phone Number | - Clinical Research experience in the pharmaceutical industry, including two (10) te. in a quality, training and compliance focused position. - Experience of 10 years acting as a quality lead within environments with complex changes, such as the integration of an acquired company, implementation of globally harmonized roles and the establishment of a pioneer working model with strategic alliance partners (with full service outsourcing). - Experience as inspection team member in FDA and EMA site inspections and as quality support in site and vendor audits. - Experience on the implementation of new processes, continuous improvement projects and quality management plans. - Experience as a certified trainer directly involved in the certification process of monitors. - Monitoring experience as Lead CRA in the implementation and conduction of simultaneous projects in Phase II-IV in diversified therapeutic areas.

Ludmila Matai Xavier

- Clinical Research experience in the pharmaceutical industry, including two (10) te. in a quality,...
Brazil

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Ludmila Matai Xavier’s Email ludmila.matai@pfizer.com

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Ludmila Matai Xavier’s Location Brazil

Ludmila Matai Xavier’s Current Industry Roche

Ludmila Matai Xavier’s Prior Industry Glaxosmithkline | Parexel | Pfizer | Abbott Laboratories

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Sr. Clinical Operations Lead

2022-03-01 00:00:00 - Present

Quality & Training Manager

2013-06-01 00:00:00 - 2015-04-01 00:00:00

Sr. Quality Specialist Process QM

2012-10-01 00:00:00 - 2013-06-01 00:00:00

Clinical Quality Lead

2010-08-01 00:00:00 - 2012-10-01 00:00:00

Jr. CRA

2004-04-01 00:00:00 - 2005-07-01 00:00:00

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Ludmila Matai Xavier is a - Clinical Research experience in the pharmaceutical industry, including two (10) te. in a quality, training and compliance focused position. - Experience of 10 years acting as a quality lead within environments with complex changes, such as the integration of an acquired company, implementation of globally harmonized roles and the establishment of a pioneer working model with strategic alliance partners (with full service outsourcing). - Experience as inspection team member in FDA and EMA site inspections and as quality support in site and vendor audits. - Experience on the implementation of new processes, continuous improvement projects and quality management plans. - Experience as a certified trainer directly involved in the certification process of monitors. - Monitoring experience as Lead CRA in the implementation and conduction of simultaneous projects in Phase II-IV in diversified therapeutic areas.