EDC Systems Lead — Oracle Clinical One | CSV & Validation

Excelya; Palaiseau; Sur place; EUR 52 000 - 76 000; Plein temps

Résumé du poste

Excelya in France is seeking a Business System Expert to bridge Clinical Data Management, IT, QA and external vendors, ensuring Oracle Clinical One performance and CSV compliance. You will provide functional support and administration for Oracle Clinical One (EDC), drive system upgrades, validation activities and training, and maintain quality documentation in line with GxP requirements.

You will monitor platform usage, manage incidents and collaborate on new system implementation scoping to

Qualifications

• Master's degree in Life Sciences, Engineering, Computer Science, or a related field.
• 2–5 years of experience in system management, system administration, or business systems support.
• Hands‑on experience with Oracle Clinical One (mandatory).
• Experience with EDC systems, eCRFs, Clinical Data Management, or Study Build activities.
• Knowledge of Computerized System Validation (CSV) and validation documentation.
• Strong understanding of clinical trial processes, ICH-GCP, and GxP requirements.
• Excellent communication and stakeholder management skills.
• Fluent English (written and spoken).

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 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

Communication skills

Stakeholder management

Fluent English

Formation

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

Outils

Oracle Clinical One

Description du poste

Excelya in France is seeking a Business System Expert to bridge Clinical Data Management, IT, QA and external vendors, ensuring Oracle Clinical One performance and CSV compliance. You will provide functional support and administration for Oracle Clinical One (EDC), drive system upgrades, validation activities and training, and maintain quality documentation in line with GxP requirements.

You will monitor platform usage, manage incidents and collaborate on new system implementation scoping to