James Guo
Director of Clinical Systems at Cytokinetics
- Role
- Director of Clinical Systems at Cytokinetics
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About James Guo
Accomplished leader with many years’ experience in Clinical Development and technology domains; extensive experience with most common clinical systems and leveraging technology to improve clinical study efficiency and ensure high quality study execution; in-depth knowledge of Pharma clinical research and end-to-end clinical development process; familiarity with system validation, 21 CFR Part 11, GCP, ICH, and other pharmaceutical regulationsDiverse experience in system fields: systems operation, support, and implementation, strategic planning and technology roadmap, RFP, vendor management, budgeting management, team building, project and portfolio management, business case and total cost of ownership analysis, change management, and new technology evaluation; expert in business intelligence and data visualization, data warehouse, systems integration, relational database, data architecture, enterprise information management
Experience
Director of Clinical Systems
May 2023 — Present · San Francisco, CA, US
Education
University of Illinois Urbana-Champaign
M.S. in Atmospheric Physics
Illinois State University
M.S. in Computer Science
Northern Illinois University
Master of Business Administration (MBA)
Nanjing University
B.S. in Physics
Skills
- Software Development Life Cycle (Sdlc)
- 21 Cfr Part 11
- Vendor Management
- Pharmaceutical Industry
- Computer System Validation
- Software Documentation
- Sdlc
- U.s. Title 21 Cfr Part 11 Regulation
- Project Management
- Cross-Functional Team Leadership
- Business Analysis
- IT Strategy
- Data Warehousing
- Sharepoint
- Business Intelligence
- Requirements Analysis
- Validation
- Integration
- Process Improvement
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