Immunology Clinical Scientist — Trial Delivery & Medical Review

Excelya; Paris; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Excelya 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 review protocols, ICFs, CRFs, and data, and collaborate with cross-functional teams to ensure quality, compliance, and timely delivery.

The role requires an advanced medical degree and strong experience in clinical development, CSR review, and TMF documentation, with fluent English.

Qualifications

• 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.

Responsabilités

• Support and represent the Study Medical Manager throughout the clinical study lifecycle.
• Contribute to the development and review of key clinical documents, including 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 teams to support data review.
• Review study-related documentation and contribute to CSRs, publications, and statistical outputs.
• Assist with study committees, investigator meetings, and study training activities.
• Maintain medical documentation within the Trial Master File (TMF).
• Draft responses to medical questions from Health Authorities, Ethics Committees, investigators, and teams.
• Develop medical review guidelines and support outsourced medical review activities.
• Support audit and inspection readiness activities and responses to findings.

Connaissances

Cross-functional collaboration

Communication skills

Formation

MD/PharmD/Life Sciences degree

Description du poste

Excelya 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 review protocols, ICFs, CRFs, and data, and collaborate with cross-functional teams to ensure quality, compliance, and timely delivery.

The role requires an advanced medical degree and strong experience in clinical development, CSR review, and TMF documentation, with fluent English.