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Clinical Systems Specialist H/F Excelya
- Saclay - 91
- CDI
- Bac +5
- Industrie Pharmaceutique • Biotechn. • Chimie
Les missions du poste
About the Job
Join Excelya, whereAudacity, Care, and Energydefine 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 enduser 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 (ICHGxP).
- 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.
Le profil recherché
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'sleading mid-size CROwith thebest employee experience. Ourone-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 caremeans 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 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 (ICHGxP)
- Education:Master's degree in a relevant field.
- Languages:Fluency in French and English is mandatory.
Bienvenue chez Excelya
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.
Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.
We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.
Publiée le 06/02/2026 - Réf : d9313f2d-5d7d-42fe-9997-d93c9ce19dac
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Clinical Systems Specialist H/F
- Saclay - 91
- CDI
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