Paula Barker Email & Phone Number

San Diego, California

PV Operations Leader. Built high performing team. Quality and Compliance expertise. Alliance partner collaboration. Vendor management. Met corporate goal saving $26mil over three years.

Greater San Diego Area

Support of Investigational and post marketing activities. SOP development, training, inspection readiness, safety management plans, product launch preparation, vendor evaluation/on-boarding/management, safety data QC/narrative preparation, regulatory intelligence, project management.

Managed team. Oversaw training strategies and operations, learning systems, annual GCP training, vendors and metrics reporting. Facilitated continuous improvement. Audit/regulatory inspection support. Training quality system implementation. Served as project manager for various training system and SOP initiatives resulting in process improvements and reduction of compliance risks.

Managed performance measurement and continuous improvement efforts. Monitored operations. Performed internal audits and risk assessments. Developed SOPs. Implemented a quality management system including training, SOPs/change control, ICSR/PSUR quality review, good documentation practices, 21 CFR Part 11, deviation investigation/CAPA procedures, product complaint/AE procedures and partner agreement compliance.

Responsible for quality review of ICSRs. Developed safety system procedures and data conventions. Facilitated serious AE reconciliation.

Managed staff and operations. Facilitated a smooth transition to new organizational structure. Assessed and implemented a new safety system. Developed workflows to facilitate the efficient review and exchange of safety data between sites.

Supervised staff and operations. Performed quality review and audits of safety documentation. Determined ICSR global reporting requirements. Prepared and submitted ICSRs/periodic safety reports in compliance with global regulations and partner agreements. Performed deviation investigations, prepared CAPAs and followed to resolution. Developed validated reports for management, regulators and development partners. Developed SOPs and partner agreements.

Mas, Health Law

in conjunction with California Western School of Law

Bs, Business And Management

Activities and Societies: Presented thesis at UCR Undergraduate Research Conference. Thesis topic: Benchmarking Training Effectiveness.

Professional Certificate, Clinical Trials Design And Management