Les missions du poste
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.
Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.
The eTMF Specialist plays a key role within the Clinical Development Platform by ensuring the quality, compliance, and inspection readiness of the electronic Trial Master File (eTMF) across global clinical trials.
This role requires strong expertise in clinical documentation management, close collaboration with crossfunctional teams, and active involvement in audits and inspections within a regulated environment.
Key responsibilities :
- Led the implementation and configuration of Veeva Vault Clinical applications, including eTMF, CTMS, Study Startup (SSU), Payments, and Site Connect.
- Facilitated requirements gathering workshops and translated business needs into scalable and compliant system solutions.
- Designed and configured Vault solutions aligned with clinical operations processes and regulatory requirements.
- Managed system validation activities, including test planning, UAT coordination, defect tracking, and compliance documentation.
- Oversaw data migration and system integration projects, ensuring data quality and seamless interoperability with external systems.
- Developed and delivered end-user and administrator training programs, supporting user adoption and change management initiatives.
- Advised stakeholders on best practices, configuration options, and alternative solutions to optimize business processes and system performance.
- Partnered closely with client project teams across global pharmaceutical companies and SMEs to ensure successful project delivery and compliance with ICH-GCP and GxP standards.
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.
- Education: Bachelor's or Master's degree in Health Sciences, Life Sciences, or related field
- Experience: Strong experience in clinical trial documentation management
- Technical Skills:
-Handson experience with Veeva Vault TMF (mandatory)
-Strong understanding of the DIA TMF Reference Model
-Experience with TMF metrics, KPIs, and dashboards
- Knowledge:
-Strong knowledge of ICH/GCP guidelines and regulatory requirements
-Understanding of clinical trial documentation lifecycle
-Knowledge of crossfunctional stakeholders (Clinical, QA, PV, Biometry, etc.)
- Languages:Fluent English (written and spoken)