Clinical Data Systems Lead (Oracle DMW)

Excelya; Saclay; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Excelya is seeking a Business System Expert to bridge Clinical Data Management, Medical Review, IT, QA, and system vendors for optimal performance and compliance of clinical data platforms.

You will provide functional support for Oracle DMW and Oracle TMS, manage incidents, and ensure CSV validation documentation while training end users and contributing to system upgrades.

Qualifications

• Master's degree in Life Sciences, Engineering, Computer Science, or 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 CSV (Computerized System Validation) 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 spoken).

Responsibilities

• Provide functional support and administration for clinical data systems, primarily Oracle DMW 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 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 scoping and assessment of new system implementation projects.

Skills

System administration

Clinical data management

Stakeholder liaison

Regulatory knowledge

Education

Master's degree

Tools

Oracle DMW

Oracle TMS

CDMS

Job description

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.

• 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 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.