Clinical Scientist Rare Disease
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Main Responsibilities: • Support the Study Medical Manager (SMM) throughout the clinical study lifecycle, from start-up to close-out. • Contribute to the development and review of protocols, amendments, informed consent forms (ICFs), and medical data validation plans. • Draft responses to medical and scientific queries from Health Authorities, Ethics Committees, study sites, and project teams. • Support the organization and management of study committees, meetings, and related documentation. • Perform medical review of patient profiles, narratives, listings, and safety data. • Collaborate with Clinical Operations, Pharmacovigilance, Data Management, and Biostatistics to support data review and consistency checks. • Review key study documents, including CRFs, validation plans, monitoring plans, and deviation listings. • Contribute to interim and final clinical study reports, statistical outputs, and scientific publications. • Support medical data review, case assessments, and clinical study management activities across therapeutic areas, including Immunology and Oncology. • Assist with audit and inspection readiness by ensuring accurate and compliant documentation.