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Clinical Scientist Rare Disease at Excelya. 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 Clinical Operations. 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. . . Support and represent. the Study Medical Manager in all study-related activities from setup to closure.. . . Contribute to the development. of trial-related documents, including protocols, informed consent forms (ICF), and amendments.. . . Draft responses. to medical queries from regulatory authorities, ethics committees, clinical sites, and study teams.. . . Assist in the preparation. and management of study committees, including member selection, charter development, and documentation.. . . Maintain and organize. medical and scientific documents in the Trial Master File (TMF).. . . Conduct clinical case reviews. , patient profile assessments, and validation of narratives.. . . Collaborate. closely with Trial Operations, pharmacovigilance, and statistics teams for data review and reporting.. . . Review key study documents. , such as risk management plans, CRFs, monitoring plans, and deviation lists.. . . Contribute to the review. of interim and final study reports, statistical tables, and clinical study reports (CSRs).. . . Prepare for audits. and inspections by ensuring compliance with medical review guidelines and regulatory standards.. . 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:.  Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum years—. talent matters most to us!. ). . . Skills: . Strong skills in reviewing clinical documents (protocols, ICFs, CSRs, etc.), Knowledge of pharmacovigilance principles and ability to perform medical data reviews, Ability to collaborate in cross-functional, international teams (e.g., medical, regulatory, PV, and biostatistics).. . . Education:.  Advanced degree in Life Sciences (PharmD, MD, PhD, or MSc in Biology, Pharmacy, or a related field).. . . Languages:.  Fluency in French & English. . Company Location: France.