Medical Monitor Senior H/F - 75

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.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.