Designer

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems.
• Perform post go-live changes (database modifications) based on updated requirement specifications in various EDC systems, provide impact assessment for modifications.
• Perform unit testing on the database design, assist User Acceptance Test (UAT) activities, and address UAT findings.
• Perform quality control (QC) review of databases designed by other designers.
• Set-up and configure the development environment for new studies.
• Assist with the creation of the Database Integration Specification with other systems, provide Integration Technical Detail as needed, program and assist with the integration and testing.
• Support the Data Manager in investigating and addressing issues related to the database design.
• Assist with study decommission and archiving.
• Develop new features and functionality within the database design functional areas to increase the efficiency of database design at the study-level and to improve and enhance the company’s database design capabilities.
• Mentor and provide guidance to new Database Designers on the procedures and best practices related to the database design.
• Review study design requirement specifications, ensuring the specifications adhere to EDC platform standards and Everest Standards with best design practice.
• Contribute to the development of database design project timelines.
• Maintain database design timelines and promote good project management practices.
• Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading and participating in relevant training and/or relevant association activities.
• Participate in EDC vendor’s technical learning and exchange meetings and other internal and external training meetings.
• Develop and maintain the company’s database design procedural documents, Work Instructions, checklists, guides, and templates for all EDC systems.
• Provide input to all database design-related data management procedural documents.
• Cooperate with and assist the Quality Assurance department with QC audits on assigned databases.
• Validate and disseminate real-time study monitoring reports to the Sponsor and internal team members.
• Participate in and contributes to Clinical Data Management initiatives.

Senior Clinical Database Designer II

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems
• Design includes case report forms (CRF), edit checks, study roles, laboratory, coder, RTSM
• Perform post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (EDC) systems
• Provide impact assessment for modifications
• Perform Unit Testing on database design
• Assist User Acceptance Test (UAT) activities
• Address UAT findings
• Setup and configure the development environment for new studies
• Assist the creation of the Database Integration Specification (DIS) with other systems
• Provide Integration Technical Detail (ITD) as needed
• Program the integration and assist the integration test
• Support Data Manager (DM) in investigating and addressing issues related to the database design
• Assist study decommission and archiving
• Develop new features and functionality within the database design functional areas to increase efficiency
• Review study design requirement specifications
• Maintain database design timelines and promote good project management practices
• Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process
• Follow up on regulatory requirements, industry trends, and best practices by participating in training and activities
• Contribute to the development and maintenance of the company’s database design procedural documents

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Senior Clinical Database Designer II

Senior Clinical Database Designer