Business System Expert Data Management Workbench
Descrizione dell'offerta
Join Excelya , where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role offers an exciting opportunity to support the systems used for clinical data cleaning and review activities. As a Business System Expert , you will act as the bridge between Clinical Data Management, Medical Review, IT, QA, and system vendors, ensuring optimal performance, compliance, and adoption of clinical data management platforms. Key Responsibilities Provide functional support and administration for clinical data systems, primarily Oracle DMW (Data Management Workbench) and Oracle TMS . Act as the main liaison between business users, IT teams, QA, and vendors. Manage incidents, track system issues, and support resolution activities. Ensure system validation activities and maintain compliant CSV (Computerized System Validation) documentation. Develop and maintain quality documentation in accordance with GxP requirements. Train and support end users on system functionalities and best practices. Participate in system upgrades, deployments, and validation activities. Monitor system usage, identify improvement opportunities, and support CAPA implementation. Contribute to the scoping and assessment of new system implementation projects. Requirements Master's degree in Life Sciences, Engineering, Computer Science, or a related field. 2–5 years of experience in system administration, clinical systems, or business systems support. Mandatory experience with Oracle DMW (Data Management Workbench) . Experience with Clinical Data Management Systems (CDMS) and clinical data review processes. Knowledge of Computerized System Validation (CSV) and validation documentation. Strong understanding of clinical trials, ICH-GCP, and GxP regulations . Experience supporting Clinical Data Management and Medical Review teams. Fluent English (written and spoke
Dettagli
- Azienda: Excelya
- Sede: Saclay, France
- Tipo di contratto: Tempo pieno
- Fonte: arbeitnow
- Valido fino al: 25 ottobre 2026
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