Clinical Trial Assistant

il y a 5 jours

Paris, France Excelya Temps plein

**About the Job**

As a Clinical Trial Assistant at Excelya, you will be at the forefront of clinical research, playing a crucial role in supporting the management of clinical trials. Our core values of **Audacity, Care, and Energy** drive us to push boundaries and create innovative solutions in the clinical landscape. This position thrives on teamwork and initiative, where every contribution counts to achieve our projects' success.

**Main Responsibilities**
- Support Clinical Project Managers and Clinical Research Associates (CRAs) in the administration and organization of clinical trials.
- Maintain the Trial Master File (TMF) and ensure all documents are compliant with ICH-GCP guidelines.
- Assist with the preparation and organization of study documentation, including regulatory submissions and site files.
- Coordinate study supplies and materials, ensuring timely distribution to sites.
- Utilize clinical trial management systems (CTMS) and electronic TMF systems to track trial progress and documentation.
- Schedule and facilitate meetings, prepare agendas, and track action items.
- Act as a liaison with clinical trial sites to manage queries and document submissions.
- Assist in site activation and closure, including regulatory document management.
- Manage administrative duties related to study contracts and vendor relationships.
- Ensure all clinical documentation is audit-ready and assist in inspection preparations.

**Requirements**:
**About You**

To be successful in the Clinical Trial Assistant role at Excelya, you possess a combination of relevant experience and a passion for clinical research.
- **Experience**: Experience in clinical trials or a related environment, with a strong emphasis on collaboration and adaptability.
- **Skills**: Solid understanding of Good Clinical Practice (GCP) and regulatory requirements. Proficiency in using CTMS and eTMF systems (e.g., Veeva Vault) is advantageous.
- **Education**: A degree in Life Sciences, Pharmacy, or a relevant field.
- **Languages**: Proficiency in both French and English is essential.

**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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