Alice Phung

Experience

1. Director, Clinical Data Strategy and Solutions

   Bristol Myers Squibb

   Jun 2021 — Present · CA, US

   Lead and provide strategy and solutions for clinical and operational data to support business processes • Collaboration with IT, business owners, reporting technology providers, and internal stakeholders to ensure systems are meeting BMS expectations and enhancement requirements are being appropriately considered in the provider’s roadmap. • Responsible for the Clinical Data Review processes, including development and execution of automation and innovation strategies through AI/ML (NLP) • Lead company acquisitions (e.g. process conversion, system, data/system flow, etc.) to enable transition of operational activities that impact CDR & A and cross functional stakeholders • Lead and support governance with Information Technology (IT) and other key stakeholders to ensure clinical data warehouse ecosystem enables an efficient, effective, and compliant delivery of clinical data • Provide operational leadership and guidance in development of Quality Documents (i.e. SOP/WIs) to Subject Matter Experts in the development and maintenance of global processes, procedures, and training materials by establishing a strategic vision to ensure efficient, effective, compliant working practices. Establish appropriate structures and processes to execute the strategy. • Serve as the central point of contact for CDR & A regarding GxP audits and inspections, coordinating with CDR & A Leaders and SMEs on the preparation and subsequent follow-up activities.

Skills

• U.s. Title 21 Cfr Part 11 Regulation
• CRO
• Clinical Research
• Project Management
• Clinical Trials
• Clinical Data
• CRO Management
• Good Clinical Practice (Gcp)
• Cdisc
• Clinical Data Management
• Oracle Clinical
• Vendor Management
• 21 Cfr Part 11
• Pharmaceutical Industry
• Edc
• Data Management
• Cross-Functional Team Leadership
• Electronic Data Capture (Edc)
• Gcp
• Regulatory Submissions
• Clinical Development