[Hiring] Senior Clinical Database Designer II @Everest Clinical Research

Role Description

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Senior Clinical Database Designer II for our Brightech location in Taipei, Taiwan, with opportunities to work remotely from a home-based office in accordance with our Work from Home policy.

• Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems, including:
  • Case Report Forms (CRFs)
  • Edit checks
  • Study roles
  • Laboratory
  • Coder
  • Randomization and trial supply management
• Perform post go-live changes (database modifications) based on updated requirement specifications in various EDC systems, providing 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, providing 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 adherence to EDC platform standards and Everest Standards with best design practice.
• Review the protocol and associated reference material to ensure that the study design specifications meet the protocol requirements.
• Contribute to the development of database design project timelines and maintain them while promoting 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, benchmarking, and best working practices in data management and database design.
• 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 contribute to Clinical Data Management initiatives.

Qualifications

• Sc. in Biological Sciences or Computer Science.
• Five years’ related experience.
• Two to three years developing Inform, DFdiscover, Clinical One and/or Medidata Rave (or similar) clinical databases.
• Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels.
• Proven leadership and interpersonal skills in complex team situations.
• Excellent presentation skills and the ability to build relationships with both internal and external clients.
• Must be well-organized and able to work independently and manage multiple projects/tasks appropriately.
• Demonstrated ability to effectively organize and integrate the activities of information processing personnel.