Clinical EDC Systems Lead (Oracle Clinical One)

Excelya Group; Saclay; Vor Ort; EUR 55.000 - 85.000; Vollzeit

Zusammenfassung

Excelya is seeking a Business System Expert to support Oracle Clinical One and related EDC platforms in our trials environment. You will bridge Clinical Data Management, IT, QA and vendors to ensure performance and compliance.

You will lead system validation activities, develop quality documentation, deliver user training and participate in upgrades, deployments and scoping of new projects, while keeping a patient-centric, quality-focused mindset.

Qualifikationen

• 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).

Aufgaben

• 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.

Kenntnisse

English fluency

Communication skills

Stakeholder management

Clinical trial knowledge

CSV knowledge

Ausbildung

Master's degree in Life Sciences/Engineering/CS

Tools

Oracle Clinical One

EDC systems

eCRFs

Clinical Data Management

Study Build

Jobbeschreibung

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.

• 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‑size 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.