EDC Systems Lead — Clinical Data Platform Expert

LesJeudis; Saclay; Hybride; EUR 65 000 - 85 000; Plein temps

Résumé du poste

Excelya is seeking a Business System Expert to support Oracle Clinical One and related EDC platforms, bridging Clinical Data Management, IT, QA, and external providers.

You will drive system validation, CSV documentation, and ongoing user training while contributing to upgrades and deployments in a GxP environment. Fluent English is required, with a focus on compliant and efficient data management.

Qualifications

• Master's degree in Life Sciences, Engineering, Computer Science, or related field.

Responsabilités

• Provide functional support and administration for Oracle Clinical One (EDC).
• Act as the primary interface between Clinical Data Management teams, IT, QA, and external providers.
• Manage incidents and coordinate resolution of technical issues.
• Ensure system validation activities and maintain compliant Computerized System Validation (CSV) documentation.
• Develop and maintain quality documentation in accordance with GxP requirements.
• Deliver user training and provide ongoing support.
• Participate in system upgrades, deployments, and validation activities.
• Monitor platform usage and drive corrective and preventive actions when needed.
• Contribute to the scoping and assessment of new system implementation projects.

Connaissances

Oracle Clinical One

EDC systems

CSV/CSV documentation

GxP/ICH-GCP

stakeholder management

training delivery

Formation

Master's degree in Life Sciences or related field

Outils

Oracle Clinical One

Description du poste

Excelya is seeking a Business System Expert to support Oracle Clinical One and related EDC platforms, bridging Clinical Data Management, IT, QA, and external providers.

You will drive system validation, CSV documentation, and ongoing user training while contributing to upgrades and deployments in a GxP environment. Fluent English is required, with a focus on compliant and efficient data management.