Senior Clinical Database Designer II

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Everest Clinical Research

WebsiteLinkedInAlle Stellen

501 - 1000 Mitarbeiter

Gegründet 2004

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Everest Clinical Research ist eine globale Clinical Research Organization (CRO), die umfassende Dienstleistungen im Bereich klinische Studien und Biometrics-Expertise für Pharma- und Biotechnologie-Sponsoren bietet. Das Unternehmen offeriert klinische Operationen und Projektmanagement, risikobasiertes Qualitätsmanagement und zentralisiertes Monitoring, medizinisches Monitoring, Pharmakovigilanz, klinisches Datenmanagement, Biostatistik und statistische Programmierung, regulatorische Strategie und Einreichungen sowie Technologielösungen wie IRT/RTSM und ePRO/eCOA. Everest positioniert sich als ein qualitativ hochwertiger Partner mit globaler Reichweite und therapeutischer Expertise in den Bereichen Onkologie, Neurologie, Atemwegserkrankungen, seltene Krankheiten und Immunologie.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• Flexible work arrangements • Professional development opportunities