Clinical Scientist Immunology

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do. As a Clinical Scientist, you will support the Study Medical Manager in the planning, execution, analysis, and reporting of clinical studies from study start-up through study close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration to ensure high-quality clinical trial delivery in compliance with regulatory requirements.

Key Responsibilities

• Support and represent the Study Medical Manager throughout the clinical study lifecycle. • Contribute to the development and review of key clinical documents, including protocols, protocol amendments, informed consent forms (ICFs), CRFs, and medical data validation plans. • Perform medical review of patient data, listings, narratives, CIOMs, and clinical cases. • Collaborate closely with Clinical Operations, Pharmacovigilance, Biostatistics, and Data Management teams to support data review and consistency checks. • Review study-related documentation and contribute to interim analyses, Clinical Study Reports (CSRs), publications, and statistical outputs. • Support the preparation and management of study committees, investigator meetings, and study training activities. • Maintain medical and scientific documentation within the Trial Master File (TMF). • Draft responses to medical questions from Health Authorities, Ethics Committees, investigators, and study teams. • Develop medical review guidelines and support outsourced medical review activities when applicable. • Contribute to audit and inspection readiness activities and support responses to findings.