Florian B.

Lead of end-to-end clinical data management activities for clinical investigations involving ophthalmic medical devices, including protocol review, eCRF/database design and validation, data cleaning and query management, reconciliation of clinical and device-generated data, oversight of external data flows, cross-functional coordination with internal teams, CROs and vendors, and contribution to regulatory compliance, inspection readiness and data governance processes.

Management of clinical data management activities across international studies, including team supervision, clinical database oversight, data cleaning and query management, cross-functional coordination with internal and external stakeholders, and ensuring data quality, consistency, and compliance throughout the study lifecycle.

Generation and management of high-quality, reliable, and statistically sound data from clinical trials. in an International Study, multicenter in pneumology (persistent asthma) (phase III- eCRF study) on behalf of Sanofi Laboratories. Activities includes also coordination between different study actors: all R&D members as well as Regulatory Affairs, Medical Affairs and Pharmacovigilance teams to coordinate and ensure the successful completion of the clinical activities within the agreed timelines and budget, and in compliance with the required quality and Good Clinical Practice.