Clinical Trial Assistant

il y a 2 semaines

Paris, France Excelya Temps plein

**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.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in 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**
- Support Clinical Project Managers and CRAs in the daily management of clinical studies in oncology (Phase I-III).
- Maintain and update the Trial Master File (TMF/eTMF) in compliance with ICH-GCP and SOPs.
- Coordinate study documentation: investigator site files, regulatory binders, ethics submissions.
- Assist with preparation, distribution, and tracking of study materials and trial supplies.
- Manage internal systems such as CTMS, eTMF (e.g., Veeva Vault), and study trackers.
- Schedule meetings, draft agendas and minutes, and follow up on action items with stakeholders.
- Liaise with investigational sites to ensure timely submission of documents and resolution of queries.
- Support site activation and close-out activities, including document collection and reconciliation.
- Handle administrative tasks related to study contracts, invoices, and vendor coordination.
- Ensure audit readiness of all clinical documentation and support inspection preparation.

**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 ability to thrive in collaborative, fast-moving environments (avoid requiring minimum years—**talent matters most to us**)
- **Skills**:Strong knowledge of PV regulatory requirements, particularly in the EU/EEA context, Experience working with international PV networks or within a Global Safety structure is a strong asset, Experience in drafting or reviewing SDEAs and interacting with vendors is a plus.
- **Education**: Degree in Pharmacy, Life Sciences, or equivalent.
- **Languages**: Fluency in French & English

**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.

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