Clinical Systems Specialist
il y a 6 jours
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.
This role is an exciting opportunity to contribute to a dynamic, ambitious team. 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
Ensure the high performance and reliability of clinical information systems supporting feasibility, monitoring and operational data management in clinical trials (e.g. Siebel CTMS)
Act as a key interface between Clinical teams, IT and external partners, ensuring business needs are properly translated into system requirements
Monitor, track and follow up on technical issues in collaboration with DDS, ensuring timely resolution and clear communication
Identify, represent and defend end‑user needs with the Information Systems department and other stakeholders (providers, QA, etc.)
Ensure that clinical systems are properly maintained, updated and compliant with internal procedures and clinical regulations (ICH‑GxP)
Maintain system documentation and computerized system validation in line with regulatory requirements
Contribute to system upgrades and improvements, including deployment and validation activities
Monitor system usage and deviations, and propose corrective and preventive actions (CAPA) when required
Ensure appropriate training and support of end users on clinical systems
Work closely with a referent Clinical Systems expert and collaborate with the broader Clinical System Management team
Requirements
About You
At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values.
Experience: Proven experience in managing international clinical operations (avoid requiring minimum years—talent matters most to us)
Skills: Proven experience with CTMS systems (Siebel CTMS strongly preferred), Experience in computerized system validation, Solid knowledge of clinical research processes and regulations (ICH‑GxP)
Education: Master's degree in a relevant field
Languages: Fluency in French and English is mandatory
Benefits
Why Join Us?
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
Niveau hiérarchique
Confirmé
Type d'emploi
Temps plein
Fonction
Analyste
Secteurs
Services et conseil en informatique
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