Clinical Scientist – Immunology

This is a fully remote position, open to applicants in France.

📋 Description

• Assist and represent the Study Medical Manager throughout the entire clinical study lifecycle.

• Aid in the development and evaluation of protocols, protocol amendments, informed consent forms (ICFs), case report forms (CRFs), and medical data validation plans.

• Conduct medical reviews of patient data, listings, narratives, Clinical Investigator Overviews (CIOMs), and clinical cases.

• Work in collaboration with Clinical Operations, Pharmacovigilance, Biostatistics, and Data Management teams on data review and consistency checks.

• Evaluate study documentation and contribute to interim analyses, Clinical Study Reports (CSRs), publications, and statistical outputs.

• Assist in the preparation and management of study committees, investigator meetings, and training activities related to the study.

• Maintain medical and scientific documentation within the Trial Master File (TMF).

• Draft responses to medical inquiries from Health Authorities, Ethics Committees, investigators, and study teams.

• Create medical review guidelines and support outsourced medical review efforts when necessary.

• Participate in audit and inspection readiness activities and assist in addressing findings.

⛳️ Requirements

• An advanced degree in Medicine (MD), Pharmacy (PharmD), Life Sciences, or a related scientific field.

• Significant experience as a Clinical Scientist, Medical Scientist, Clinical Research Physician, or in a comparable role.

• Experience in supporting clinical studies in Immunology & Inflammation and/or Oncology.

• Comprehensive understanding of clinical development, study design, and the conduct of clinical trials.

• Familiarity with ICH-GCP, regulatory standards, and clinical research methodologies.

• Experience in reviewing clinical data, patient profiles, narratives, and safety information.

• Knowledge of Clinical Study Reports (CSRs), protocols, and TMF documentation.

• Strong skills in cross-functional collaboration and effective communication.

• Proficient in English, both written and spoken.

🏝️ Benefits

• Opportunity for growth through a variety of stimulating projects.

• Collaboration with industry-leading experts.

• Contribution to scientific, operational, and human knowledge.

• A workplace that values innate talents and encourages boldness.

• Opportunities to challenge limits and develop professional potential.

• Experience as part of a young and ambitious healthcare organization.

• Work within a comprehensive service model that combines full-service, functional service provider, and consulting.

• A teamwork-oriented environment.

• Contribution to enhancing the patient journey.