Senior Medical Monitor

Job Title: Senior Medical Monitor Location: EU/Non EU Type: Remote, Freelance About the Job 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 Affairs. 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 Responsibilities: Management of set-up activities for Medical Monitoring on Clinical trials including: Review of specific documents for the study (Synopsis, Protocol, eCRF, Validation plan, consent and disclosure forms etc.,), Elaborates the Medical Review strategy and Writing of the Medical Review Plan. Contribution to the protocol medical criteria compliance follow-up strategy through MedDRA and WHODD list of codes), Clinical Database Specification Review (MedDRA and WHODD coding). Contribution to Investigators' meeting, monitors meeting, etc. Management of follow-up activities, including: Medical review of Data through “patient profiles, listings, etc. Issue and follow-up of queries in the eCRF, protocol deviations management (including the creation or versioning of MedDRA / WHODD lists of codes). If needed, MedDRA and WHODD Coding and Quality Control of coded data. Can participate in the re-evaluation of the seriousness of adverse events and in the reconciliation process between the PV and the Clinical Database. Involvement in Study team meetings, Study committees, and Medical Review Focus meetings. Review of specific documents all along the study (Amendment, Medical Review Plan). Throughout the study, close collaboration with other actors of the Clinical study (Global Safety, Data Management, Trial Operation, Global Medical Affairs, etc.). Management of end of study activities, including: blind review activities (listings review, meeting), post-blind review actions and final review before database lock. Participation in the review of the final study report and associated statistical tables, and draft for publication. To be available to the study team or participants to support the protocol, safety, and other medical and procedure-related queries. 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. Experience: 2-3 years of experience in the clinical research area and/or in the Medical Monitoring or Clinical Development fields. Skills: Good communication and organizational skills, Trained in GCP, good training skills, strong team spirit, good computer skills (Excel in particular and basic programming languages: SQL, SAS). Knowledge of WhoDRUG and MedDRA are considered a plus. Education: Medical Doctor degree/pharmacy degree or any other relevant degree in life sciences. Languages: Fluent in English (written and spoken). 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. Apply today, become an Excelyate!