Trial Operations Product Management teamAll things Veeva Vault Clinical, with a focus on monitoring and study start-up features

Veeva Vault Clinical CTMS and SSU System Owner• Led the successful launch of a unified Clinical Trial Management System (CTMS) that converged four legacy systems into one• Oversaw 3-month hypercare period to stabilize business processes and technology impacted by new CTMS launch• Partner with IT to set and drive a clear roadmap for the business capability that follows SDLC/IT Validation methodologies inclusive of demand management, release planning for GxP controlled system configuration and release management• Ensured all technology solutions deliver value, improve user experience, prioritize business needs and adhere to company SOPs and regulatory requirements (ICH GCP, 21 CFR Part 11, EUCTR)• Developed and implemented operational support model and training delivery plan to support the evolving needs from a business process and system lifecycle management perspective, notably establishing a global network of 150+ Super Users to facilitate user adoption and meet emergent training needs • Planned and executed extended system outage period to permit migration of 8 million records during 2 week period, ensuring business continuity and rapid adoption at product launch• Developed data migration plans, oversaw data migration testing and production runs, and facilitated additional data migration not initially included in the scope• Contributed to internal/external continuous improvement initiatives, including Quantum Leap and Transcelerate• Participated in internal audits and external inspections for the business capability to ensure data requests by auditors and agencies are handled expeditiously. Developed corrective and preventative action plans (CAPA).• Reviewed and approved capability lifecycle documents supporting system validation and change requests. Lead User Acceptance Testing component of system validation. • Presented at industry conference (Veeva Summit) focusing on the transformation of CTMS and lessons learned with 2000+ attendees

Early Development and Clinical Pharmacology. Phase 1 Oncology Trial Manager responsible for operational oversight of protocols from start-up to database lock.

Phase 1 Oncology Site Manager, Early Development and Clinical Pharmacology

Assigned to Novartis Oncology drug development protocols. A newly formed team within the Global Monitoring Operations (GMO), the Monitoring Optimization and Innovation (MOI) Flex team has site management responsibilities nationwide.

July 2012 through December 2013; Contracted partner with Janssen Research & Development, a subsidiary of Johnson & Johnson. Resourced to Janssen oncology drug development protocols with clinical site management responsibilities nationwide.June 2009 through July 2012; Contracted partner of Amgen. Work exclusively on the Amgen drug pipeline, with clinical site management responsibilities in the South region. Areas of focus include hematology/oncology, cardio renal, bone, and oncology supportive.

Pediatric hematology/oncology research coordinator

Institute for Drug Development - Phase 1 Oncology unit