Senior Clinical Database Designer II

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

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 database for new studies based on requirement specifications in various electronic data capture (EDC) systems. • Perform post go-live changes (database modifications) based on updated requirement specifications in various EDC systems, provide 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, provide 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 the specifications adhere to EDC platform standards and Everest Standards with best design practice. • Contribute to the development of database design project timelines. • Maintain database design timelines and promote good project management practices. • Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading and participating in relevant training and/or relevant association activities. • 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 contributes to Clinical Data Management initiatives.

🎯 Requirements

• B.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.

🏖️ Benefits

• Flexible work arrangements • Professional development opportunities