Designer

• Design clinical databases for new studies in various electronic data capture (EDC) systems, including CRFs, edit checks, study roles, laboratory, coder, and RTSM
• Perform post-go-live database modifications and provide impact assessments
• Perform unit testing, assist user acceptance testing, and address UAT findings
• Set up and configure development environments for new studies
• Assist with Database Integration Specifications, provide Integration Technical Details, program integrations, and assist integration testing
• Support Data Managers in investigating and addressing database design issues
• Assist study decommissioning and archiving
• Develop database design features and functionality to improve study-level efficiency and company capabilities
• Review study design specifications for EDC platform and Everest standards compliance
• Review protocols and reference materials to ensure database design specifications meet protocol requirements
• Contribute to database design project timelines and maintain database design timelines
• Assist Clinical Data Management in planning, directing, and managing database design and maintenance
• Follow regulatory requirements, industry trends, benchmarking, and best practices in data management and database design
• Participate in EDC vendor technical learning and exchange meetings and other training meetings
• Contribute to database design procedures, work instructions, checklists, and templates
• Provide input to database design-related data management procedures
• Cooperate with Quality Assurance on quality control audits
• Validate and disseminate real-time study monitoring reports to sponsors and internal team members
• Participate in Clinical Data Management initiatives

Senior Clinical Database Designer I

• Design clinical databases for new studies in various electronic data capture (EDC) systems, including CRFs, edit checks, study roles, laboratory, coder, randomization, and trial supply management
• Perform post-go-live database modifications and impact assessments
• Perform unit testing, assist with User Acceptance Testing, and address UAT findings
• Conduct quality-control reviews of databases designed by other designers
• Set up and configure development environments for new studies
• Create Database Integration Specifications, provide integration technical details, and assist with integration and testing
• Support Data Managers in investigating and resolving database-design issues
• Assist with study decommissioning and archiving
• Develop database-design features and functionality to improve study-level efficiency and company capabilities
• Mentor and guide new Database Designers on procedures and best practices
• Review study design specifications and protocols for EDC and Everest standards compliance
• Contribute to and maintain database-design project timelines
• Assist Clinical Data Management with planning, directing, and managing database design and maintenance
• Monitor regulatory requirements, industry trends, benchmarking, and data-management best practices
• Participate in EDC vendor technical meetings and training
• Develop and maintain database-design procedural documents, work instructions, checklists, guides, and templates
• Assist Quality Assurance with QC audits on assigned databases
• Validate and disseminate real-time study monitoring reports to sponsors and internal team members
• Participate in Clinical Data Management initiatives

Designer jobs in Taiwan

Senior Clinical Database Designer I

Senior Clinical Database Designer – II