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Thursday, November 5 • 10:20am - 11:05am
Discuss CRO, Sponsor, and Site Collaboration and Best Practices

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Moderators
avatar for Vittoria Sparacio

Vittoria Sparacio

Global Head, Clinical Document Governance & Management, Novartis
Vittoria has recently joined Novartis as Global Head, Clinical Document Governance & Management. She was previously with GSK Pharmaceutical R&D where she headed up the Clinical Documentation group and established document management processes, systems and standards for quality and... Read More →

Speakers
avatar for Stephanie Mayew

Stephanie Mayew

Manager of Clinical Operations, PRA Health Sciences
Stephanie Mayew has 17 years of clinical research experience and is currently the Business Lead for implementation of a new eTMF solution. She is also responsible for management of TMF Global Services in accordance with PRA policies, procedures, SOPs, ICH-GCP guidelines, local regulatory... Read More →
avatar for Joanne Malia

Joanne Malia

Director, Clinical Documentation Management, Regeneron Pharmaceuticals, Inc.
Joanne Malia is Director, Clinical Documentation Management at Regeneron Pharmaceuticals and responsible for the TMF group and Clinical Archives and is the Business Process Owner for the eTMF.  Throughout her 25+ year career in life sciences she has worked for diagnostic, biotech... Read More →
avatar for Leanne Rice

Leanne Rice

Clinical Documentation Manager, GSK
Leanne graduated from the London School of Hygiene & Tropical Medicine, joining GSK in 1992 as a Statistician. Leanne worked on clinical trials, being involved with all aspects from protocol writing to reporting and publication. The role expanded to cover other areas such as Investigator... Read More →
avatar for Pawel Rucki

Pawel Rucki

Senior Manager, TMF Operations Clinical Operations Excellence, GW Pharmaceuticals
Pawel joined GW Pharmaceuticals in September 2015 in the newly created role of Clinical Process Improvement Officer and was responsible for developing and executing restructure of the TMF. Shortly after he became a Manager in Clinical Process Improvement and in 2018 Pawel spear-headed... Read More →


Thursday November 5, 2020 10:20am - 11:05am EST