Shanon Phillips Email & Phone Number

• Operational support: ensure consistency of implementation of quality standards in the affiliate. • Process management: ensure affiliate processes are aligned with local and global Roche-GNE SOPs, regulatory requirements and are documented and consistently applied. • Training: support the delivery of effective training programs for affiliate staff (including in-sourced CRO staff, if applicable) in compliance with global and local requirements.• Quality Risk Management: implement affiliate Quality Risk Management and Inspection Readiness approaches. • RBM NA Champion: Support NACCO with embedding of RBM

Collierville, Tn

• Responsible for complete site management• Site feasibility, pre-study, contract/budget development, collected start-up documents, completed study initiation and monitoring visits, • Educated site personnel regarding EDC system, documented discrepancies per EDC, closed discrepancies per EDC, locked patient CRFs, completed close out visits, trained sites for EDC refresher information

Collierville, Tn

• Responsible for accurate and timely monitoring of multidiscipline therapeutic protocols• Site management, verified study files, drug accountability, ensured adequate clinical supplies, retrieved complete/accurate data to achieve deadlines• Identified potential investigators for upcoming projects