Senior Clinical Database Designer I

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

📋 Description

• Create clinical databases for new studies utilizing various electronic data capture (EDC) systems, which includes CRFs, edit checks, study roles, laboratory, coder, and RTSM.

• Implement modifications to databases post-go-live and provide assessments on their impact.

• Conduct unit testing, assist with user acceptance testing, and address findings from UAT.

• Establish and configure development environments for new studies.

• Aid in the creation of Database Integration Specifications, supply Integration Technical Details, program integrations, and assist with integration testing.

• Assist Data Managers in identifying and resolving database design challenges.

• Support the decommissioning and archiving of studies.

• Design database features and functionalities aimed at enhancing study-level efficiency and the company's capabilities.

• Evaluate study design specifications for compliance with EDC platform and Everest standards.

• Analyze protocols and reference materials to ensure that database design specifications align with protocol requirements.

• Contribute to the timelines for database design projects and ensure they are maintained.

• Assist Clinical Data Management in the planning, direction, and oversight of database design and maintenance.

• Adhere to regulatory requirements, industry trends, benchmarking, and best practices in data management and database design.

• Engage in EDC vendor technical learning sessions and other training meetings.

• Contribute to the development of database design procedures, work instructions, checklists, and templates.

• Provide insights for data management procedures related to database design.

• Collaborate with Quality Assurance on quality control audits.

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

• Take part in Clinical Data Management initiatives.

⛳️ Requirements

• Bachelor’s degree in Biological Sciences or Computer Science.

• Five years of relevant experience.

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

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

• Demonstrated leadership and interpersonal skills within complex team environments.

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

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

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

🏝️ Benefits

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