Business System Expert Clinical One

Excelya; Saclay; Sur place; EUR 70 000 - 95 000; Plein temps

Résumé du poste

Excelya in Saclay, Île-de-France, is seeking a Business System Expert to bridge Clinical Data Management, IT, QA, and system vendors for Oracle Clinical One and related EDC platforms. You will ensure performance, compliance, and continuous improvement of the systems used for clinical data collection in trials.

Responsibilities include incident management, system validation, training delivery, and supporting upgrades and validation activities, while maintaining CSV documentation and adherence 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 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

Stakeholder management

Communication

Training delivery

Incident management

Formation

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

Outils

Oracle Clinical One

Description du poste

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 collection and management in clinical trials. As a Business System Expert , you will act as the bridge between Clinical Data Management, IT, QA, and system vendors, ensuring the performance, compliance, and continuous improvement of Oracle Clinical One and related EDC platforms.

Key Responsibilities

• 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.

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).

Why join us?

At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare. Here's what makes us unique: We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience. Our "one-stop provider" service model-combining full-service, functional service provider, and consulting-allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey. Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.