Senior Clinical Database Designer

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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 • Design includes case report forms (CRF), edit checks, study roles, laboratory, coder, RTSM • Perform post go-live changes (database modifications) based on updated requirement specifications in various electronic data capture (EDC) systems • Provide impact assessment for modifications • Perform Unit Testing on database design • Assist User Acceptance Test (UAT) activities • Address UAT findings • Setup and configure the development environment for new studies • Assist the creation of the Database Integration Specification (DIS) with other systems • Provide Integration Technical Detail (ITD) as needed • Program the integration and assist the integration test • Support Data Manager (DM) in investigating and addressing issues related to the database design • Assist study decommission and archiving • Develop new features and functionality within the database design functional areas to increase efficiency • Review study design requirement specifications • Maintain database design timelines and promote good project management practices • Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process • Follow up on regulatory requirements, industry trends, and best practices by participating in training and activities • Contribute to the development and maintenance of the company’s database design procedural documents

🎯 Requirements

• B.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 • 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, able to work independently, and manage multiple projects/tasks appropriately • Demonstrated ability to effectively organize and integrate the activities of information processing personnel.

🏖️ Benefits

• Work from Home policy • Opportunities to work remotely