Medical Monitor Junior

il y a 3 jours

Paris, France Excelya Temps plein

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 Medical Monitoring. 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 Responsabilities:

- Ensure compliance with sponsors’ and Excelya’s SOPs, international/local regulations, and remain updated on any changes.
- Conduct literature reviews to support project requirements.
- Edit and review clinical study documents in line with SOPs.
- Manage set-up activities for Medical Monitoring: review study documents (protocols, synopses, eCRFs, consent forms, validation plans), define medical review strategy and plans, support compliance strategies, and review database specifications (MedDRA/WHODD coding).
- Oversee follow-up activities: medical data review (patient profiles, listings), query management, protocol deviations, coding (MedDRA/WHODD), quality control of coded data, AE seriousness re-evaluation, reconciliation with PV databases, and continuous review of amendments and plans.
- Collaborate with other stakeholders (Global Safety, Data Management, Trial Operations, Global Medical Affairs, etc.) throughout the study.
- Manage end-of-study activities: blind review, post-blind review, final review before database lock, and contribute to study reports, statistical tables, and publication drafts.

**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.
- Medical degree (MD or equivalent) required.
- Relative experience of up to 1 year in the clinical research area and/or in the Medical Monitoring or Clinical Development fields is considered a plus.
- Experience in clinical trials, medical monitoring, or pharmacovigilance.
- Strong knowledge of ICH-GCP, MedDRA, WHODD, and relevant international/local regulations.
- Excellent analytical and problem-solving skills.
- Ability to collaborate with multidisciplinary teams and stakeholders.
- Strong communication, writing, and document review skills.
- Proactive, detail-oriented, and adaptable to evolving project needs.

**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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