Senior Clinical Database Designer – II

This is a fully remote position, open to applicants in Taiwan.

📋 Description

• Design clinical databases for new studies utilizing various electronic data capture (EDC) systems, which include CRFs, edit checks, study roles, laboratory, coder, randomization, and trial supply management.

• Execute post-launch modifications to databases and conduct impact assessments.

• Conduct unit testing, support User Acceptance Testing, and address any findings from UAT.

• Perform quality-control reviews of databases developed by other designers.

• Set up and configure development environments for new studies.

• Create Database Integration Specifications, offer integration technical details, and assist in both integration and testing processes.

• Provide support to Data Managers in troubleshooting and resolving database design issues.

• Aid in the decommissioning and archiving of studies.

• Develop features and functionalities in database design to enhance study-level efficiency and company capabilities.

• Mentor and guide new Database Designers on procedures and best practices.

• Review study design specifications and protocols to ensure compliance with EDC and Everest standards.

• Contribute to and maintain timelines for database design projects.

• Assist Clinical Data Management in planning, directing, and managing database design and maintenance tasks.

• Stay updated on regulatory requirements, industry trends, benchmarking, and best practices in data management.

• Participate in technical meetings and training sessions with EDC vendors.

• Develop and maintain procedural documents related to database design, including work instructions, checklists, guides, and templates.

• Assist Quality Assurance with QC audits on assigned databases.

• Validate and distribute real-time study monitoring reports to sponsors and internal team members.

• Engage in Clinical Data Management initiatives.

⛳️ Requirements

• Bachelor of Science in Biological Sciences or Computer Science.

• Five years of relevant experience.

• Two to three years of experience in developing Inform, DFdiscover, Clinical One, and/or Medidata Rave (or similar) clinical databases.

• Strong oral and written communication skills with personnel at all professional and administrative levels.

• Demonstrated leadership and interpersonal skills in complex team environments.

• Excellent presentation skills with the ability to foster relationships with both internal and external clients.

• Highly organized, capable of working independently, and proficient in managing multiple projects/tasks effectively.

• Ability to efficiently organize and integrate the activities of information processing personnel.

🏝️ Benefits

• Opportunities for remote work from a home-based office in line with the Work from Home policy.

• Relevant training and association activities.

• Participation in EDC vendor technical learning and exchange meetings.

• Internal and external training meetings.