Clinical Scientist Rare Disease H/F - 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.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.

As a Clinical Scientist, you will act as a delegate for the Clinical Research Physician and support a variety of medical and scientific activities related to clinical trials. Your scope may include :
- Participating in the writing and review of study documents such as informed consent forms, protocol amendments, medical data validation plans, and responses to medical questions.
- Contributing to meetings with investigators, monitors, and internal teams; participating in the management of study-related committees.
- Conducting medical review of clinical data and collaborating closely with Pharmacovigilance and Clinical Operations to ensure data consistency.
- Reviewing and providing input on study documentation, ensuring medical accuracy and relevance throughout the trial.
- Contributing to the review of Clinical Study Reports (CSRs), associated statistical tables, and drafting scientific publications.
- Managing the electronic filing and archiving of trial documentation in compliance with regulatory and internal standards.
- Performing medical case reviews, analyzing patient listings, and supporting the overall clinical study management process (study setup, site training, process-related queries) within a global study context.
- Ensuring clarity and consistency in medical reports and participating in responses to medical queries and data clarification.
- Reviewing medical guidelines and providing support for outsourced medical review activities.

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 :Experience in clinical research, ideally in a Clinical Project Manager or Clinical Scientist role.
- Skills :Previous involvement in early phase clinical trials or rare disease studies is a strong asset, Strong analytical and critical thinking skills with proven ability to interpret complex clinical data, Experience in cross-functional collaboration, particularly with Pharmacovigilance, Biostatistics, and Medical Affairs teams.
- Education :Master's degree in Life Sciences (minimum Bac +5), PharmD, or PhD in a relevant scientific field.
- Languages :Fluent in English (written and spoken); French is a plus.