Medical Monitor Senior

il y a 3 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 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 strict adherence to sponsors’ and Excelya’s SOPs, guidelines, and all applicable legislation.
Stay updated on amendments to laws, procedures, and relevant medical literature.
Conduct literature reviews according to project requirements.
Edit and review clinical study documents (protocols, synopses, eCRFs, validation plans, consent forms, amendments, etc.).
Provide support for safety, protocol, and procedure-related queries from study teams and participants.
**Manage set-up activities for Medical Monitoring**:
Review study documents and database specifications (MedDRA/WHODD coding).
Define the medical review strategy and write the Medical Review Plan.
Contribute to protocol compliance and coding strategy.
Participate in investigator and monitor meetings.
**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.
University graduate in life sciences (postgraduate studies in a relative field are considered a plus)
Relative experience of up to 3 years in the clinical research area and/or in the Medical Monitoring or Clinical Development fields is considered a plus.
Strong experience in clinical trials, medical monitoring, or pharmacovigilance.
Expertise in ICH-GCP, MedDRA, WHODD, and applicable regulations.
Excellent analytical, problem-solving, and decision-making skills.
Strong communication and writing abilities for document review and cross-functional collaboration.
Ability to manage multiple projects and adapt to evolving priorities.
Proactive, detail-oriented, and team-focused
Fluent in english
Good computer skills (Excel in particular and basic programming languages: SQL, SAS), and knowledge of WhoDRUG and MedDRA are considered a plus.

**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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