Global Clinical Project Manager Rare Disease H/F Excelya
- Paris - 75
- 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 Clinical Operations. 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
- Lead the global management of outsourced Phase II-III clinical trials, ensuring alignment with sponsor expectations, timelines, and quality standards.
- Act as the primary point of contact for internal sponsor teams and CROs, driving collaborative decision-making and proactive issue resolution.
- Review and validate project plans developed by CROs, including risk mitigation, escalation strategy, and communication plans.
- Oversee study budgets, monitor expenses, and ensure financial reporting in coordination with CROs and sponsor finance teams.
- Ensure trials are conducted according to ICH-GCP, SOPs, and applicable regulatory requirements across all geographies.
- Supervise cross-functional study teams, fostering coordination between Clinical Operations, Medical, Biometry, Pharmacovigilance, and CMC.
- Manage vendor and site relationships, including feasibility, selection, contracting, and performance follow-up.
- Review critical study documentation: protocols, CRFs, risk management plans, and recruitment strategies.
- Participate in audits and inspections, ensure CAPA implementation, and support continuous improvement initiatives.
- Contribute to study reporting and results publication in clinical registries, in compliance with transparency regulations.
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 ability to thrive in collaborative, fast-moving environments (avoid requiring minimum years-talent matters most to us!)
- Skills:Experience in global clinical project management in CRO, pharma, or biotech settings, Knowledge of clinical study lifecycle, regulatory expectations, and quality standards.
- Education:Master's Degreeinascientific,clinical,orresearch-relatedfield
- Languages:French & Fluent in English
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.
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Publiée le 10/09/2025 - Réf : 5b147dc6-a60e-4137-87af-50379738daf6
Global Clinical Project Manager Rare Disease H/F
- Paris - 75
- CDI
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