Medical Monitor Junior 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 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.