Clinical Data Manager – France

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At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

1. Ensure implementation, monitoring, and adherence to deadlines for Data Management activities from study initiation to database lock.
2. Define and enforce quality, safety, and compliance standards to guarantee data integrity and availability according to usage requirements.
3. Supervise and organize Data Management activities conducted by CROs, ensuring efficient execution.
4. Coordinate interactions between CROs and project teams for all Data Management activities.
5. Review and approve study documents, including Data Management Plan (DMP), Data Validation Plan (DVP), and Data Review Plan (DRP).
6. Coordinate CRF design, eCRF setup, including annotated CRF and specifications, and database validation and consistency checks.
7. Monitor data collection, supporting data validation, review, and reconciliation processes.
8. Ensure that database lock activities are followed and properly documented.
9. Maintain eTMF to ensure compliance and organization.
10. Represent Data Management in project meetings and ensure compliance with SOPs, ICH/GCP, and regulatory requirements.
11. Provide Data Management expertise to optimize project execution.
12. Contribute to CRO selection and assist in updating quality documents and standards in the Data Management scope.