Senior Clinical Database Designer I

🔥 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, and RTSM • Perform post-go-live database modifications and provide impact assessments • Perform unit testing, assist user acceptance testing, and address UAT findings • Set up and configure development environments for new studies • Assist with Database Integration Specifications, provide Integration Technical Details, program integrations, and assist integration testing • Support Data Managers in investigating and addressing database design issues • Assist study decommissioning and archiving • Develop database design features and functionality to improve study-level efficiency and company capabilities • Review study design specifications for EDC platform and Everest standards compliance • Review protocols and reference materials to ensure database design specifications meet protocol requirements • Contribute to database design project timelines and maintain database design timelines • Assist Clinical Data Management in planning, directing, and managing database design and maintenance • Follow regulatory requirements, industry trends, benchmarking, and best practices in data management and database design • Participate in EDC vendor technical learning and exchange meetings and other training meetings • Contribute to database design procedures, work instructions, checklists, and templates • Provide input to database design-related data management procedures • Cooperate with Quality Assurance on quality control audits • Validate and disseminate real-time study monitoring reports to sponsors and internal team members • Participate in Clinical Data Management initiatives

🎯 Requirements

• Sc. in Biological Sciences or Computer Science • Five years’ related experience • Two to three years developing Inform, iDatafax/DFdiscover, Clinical One and/or Medidata Rave (or similar) clinical databases • Effective oral and written communication with personnel on 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 from a home-based office in accordance with the Work from Home policy