Senior Clinical Scientist Immunology
Excelya
Περιγραφή θέσης
About the role
Join Excelya, a company driven by audacity, care and energy, where innovation and collaboration are at the heart of everything we do. As a Senior Clinical Scientist in Immunology you will support the Study Medical Manager throughout the clinical study lifecycle, from start‑up to close‑out, ensuring high‑quality trial delivery in compliance with regulatory requirements.
Key responsibilities
- Support and represent the Study Medical Manager across all phases of the study.
- Develop and review clinical documents such as protocols, amendments, ICFs, CRFs and data validation plans.
- Perform medical review of patient data, listings, narratives, CIOMs and clinical cases.
- Collaborate with Clinical Operations, Pharmacovigilance, Biostatistics and Data Management to ensure data consistency.
- Contribute to interim analyses, Clinical Study Reports, publications and statistical outputs.
- Prepare and manage study committees, investigator meetings and training activities.
- Maintain medical and scientific documentation in the Trial Master File.
- Draft responses to medical queries from health authorities, ethics committees and investigators.
- Develop medical review guidelines and support outsourced review activities.
- Assist with audit and inspection readiness and respond to findings.
Required profile
- Advanced degree in Medicine (MD), Pharmacy (PharmD), Life Sciences or related discipline.
- Strong experience as a Clinical Scientist, Medical Scientist, Clinical Research Physician or similar role.
- Experience supporting immunology & inflammation and/or oncology clinical studies.
- Deep understanding of clinical development, study design and trial conduct.
- Knowledge of ICH‑GCP, regulatory requirements and clinical research processes.
- Proficiency in reviewing clinical data, patient narratives and safety information.
- Familiarity with Clinical Study Reports, protocols and TMF documentation.
- Excellent cross‑functional collaboration and communication skills.
- Fluent written and spoken English.
What we offer
Excelya combines a passion for science with teamwork to redefine excellence in healthcare. As a young, ambitious CRO aiming to become a leading mid‑size player in Europe, you will work on diverse projects, collaborate with leading experts and contribute to improving the patient journey.
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