Senior Clinical Database Designer – II

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🔥 0 minutes ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟠 Senior

✍️ Designer

👻 Ghost score 10%

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• 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

🎯 Requirements

• Bachelor of Science 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 • Effective oral and written communication with personnel at all professional and administrative levels • Proven leadership and interpersonal skills in complex team situations • Excellent presentation skills and ability to build relationships with internal and external clients • Well-organized, able to work independently, and able to manage multiple projects/tasks appropriately • Ability to effectively organize and integrate the activities of information processing personnel

🏖️ Benefits

• Remote work opportunities from a home-based office in accordance with the Work from Home policy • Relevant training and association activities • EDC vendor technical learning and exchange meetings • Internal and external training meetings