Senior Immunology Clinical Scientist – Study Leader

Excelya; France; Remote; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Excelya in France is seeking a Clinical Scientist to support the Study Medical Manager across the full clinical study lifecycle, from start-up to close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration.

The ideal candidate holds an MD/PharmD or related life sciences degree, with experience in immunology or oncology, and a strong grasp of ICH-GCP and regulatory requirements.

Qualifikationen

• Advanced degree in Medicine (MD), Pharmacy (PharmD), Life Sciences, or related scientific discipline.
• Strong experience as a Clinical Scientist, Medical Scientist, Clinical Research Physician, or similar role.
• Experience supporting clinical studies in Immunology & Inflammation and/or Oncology.
• Strong understanding of clinical development, study design, and clinical trial conduct.
• Knowledge of ICH-GCP, regulatory requirements, and clinical research processes.
• Experience reviewing clinical data, patient profiles, narratives, and safety information.
• Familiarity with CSRs, protocols, and TMF documentation.
• Fluent English, written and spoken.

Aufgaben

• 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 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, 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 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.

Kenntnisse

Cross-functional collaboration

Communication skills

Fluent English

Ausbildung

MD/PhD in Medicine/Life Sciences

Jobbeschreibung

Excelya in France is seeking a Clinical Scientist to support the Study Medical Manager across the full clinical study lifecycle, from start-up to close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration.

The ideal candidate holds an MD/PharmD or related life sciences degree, with experience in immunology or oncology, and a strong grasp of ICH-GCP and regulatory requirements.