Senior Immunology Clinical Scientist - Trials Expert

Excelya; Paris; Sur place; EUR 65 000 - 110 000; Plein temps

Résumé du poste

Excelya is seeking a Clinical Scientist to support the Study Medical Manager in planning, execution, analysis, and reporting of clinical studies from start-up to close-out. You will contribute to protocol development, medical data review, and cross-functional collaboration to ensure regulatory-compliant trial delivery.

The role requires an advanced degree and strong experience in immunology/inflammation or oncology, with a focus on clinical development and TMF documentation.

Qualifications

• Advanced degree required (MD, PharmD, Life Sciences) and related disciplines.
• Experience as Clinical Scientist or similar role.
• Experience in Immunology & Inflammation and/or Oncology.
• Strong understanding of clinical development, study design, and trial conduct.
• Knowledge of ICH-GCP and regulatory requirements.
• Fluent English, written and spoken.

Responsabilités

• Support and represent the Study Medical Manager throughout the clinical study lifecycle.
• Develop and review 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 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.

Connaissances

Clinical Scientist experience

Medical Scientist background

Regulatory & ICH-GCP knowledge

Medical data review

Cross-functional collaboration

Fluent English

Formation

Advanced degree in Medicine/Pharmacy/Life Sciences

Description du poste

Excelya is seeking a Clinical Scientist to support the Study Medical Manager in planning, execution, analysis, and reporting of clinical studies from start-up to close-out. You will contribute to protocol development, medical data review, and cross-functional collaboration to ensure regulatory-compliant trial delivery.

The role requires an advanced degree and strong experience in immunology/inflammation or oncology, with a focus on clinical development and TMF documentation.