Medical Monitor Junior

il y a 2 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.

  • Medical monitor

    il y a 1 semaine

    Paris, France Institut du Cerveau et de la Moelle Épinière Temps plein

    Main MissionsUnder the responsibilities of Neurotrials’ director, your missions will be:Manage NEUROTRIALS Medical partProvide contribution/input to the medical documentationServe as medical monitor for clinical trials conducted at the ICM in partnership with pharma/biotech/medtech companiesProvide medical expertise in protocol designParticipate in...

  • Medical Monitor Junior

    il y a 2 jours

    Paris, France Excelya Temps plein

    HybridOperations, Medical AffairsFull time Paris, Île-de-France, France OVERVIEW Description 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...

  • Medical Monitor

    il y a 7 jours

    Paris, Île-de-France PSI CRO Temps plein

    Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we...

  • Medical Monitor Senior

    il y a 2 jours

    Paris, France Excelya Temps plein

    HybridOperations, Medical AffairsFull time Paris, Île-de-France, France OVERVIEW Description 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...

  • Medical Monitor

    il y a 1 semaine

    Paris, France PSI CRO Temps plein

    PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights...

  • Monitor - Consultant junior Stratégie (F/H)

    il y a 3 jours

    Paris La Défense, France Deloitte Temps plein

    Tous nos postes sont ouverts au télétravail.Rejoindre Deloitte, c'est dire oui à une expérience qui a du sens, celle où les rencontres et les missions vous poussent à grandir chaque jour. C'est évoluer dans un environnement de travail fondé sur la confiance, la transmission et l'intelligence collective pour construire l'avenir de nos clients. Un...

  • Medical Monitor

    il y a 1 semaine

    Paris, France PSI CRO Temps plein

    Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we...

  • Commercial(e) Junior IDF Nord Dispositif Médical

    il y a 1 semaine

    Paris, France AXEME Temps plein

    Notre client, une société spécialisée dans la distribution de matériel médical en anesthésie réanimation, recrute actuellement un Responsable Commercial Junior pour le secteur IDF Nord.Missions principales :Être l’interlocuteur privilégié de l’ensemble des décideurs et prescripteurs (ingénieurs biomédicaux, pharmaciens, médecins...

  • Tarificateur Médical Junior

    il y a 1 semaine

    Paris, France AXA Partners Temps plein

    Au sein de l’équipe de Sélection des risques d’AXA Partners SAS, nous recherchons notre futur **Tarificateur Médical Junior H/F** dans le cadre d’une alternance de 24 mois (Poste basé à Chatillon). Vos principales missions seront les suivantes: - Sélection du Risque de Niveau 1 (contrats emprunteurs) - Déclenchement des formalités médicales...

  • Junior Area Manager Mm6

    il y a 2 jours

    Paris, France Margiela Temps plein

    **Junior Area Manager MM6**: - Sales- Margiela- Full time- Location: Paris, FR- Date: Oct 28, 2024**Junior Area Manager MM6**: - Description: - Maison Margiela is a Paris-based fashion house founded in 1988 by Belgian designer Martin Margiela. Celebrating unconventional aesthetics and embracing the philosophy that fashion is an art of expression rather...