Clinical Scientist – Rare Disease

This is a fully remote position, open to applicants in France, +1 more country.

📋 Description

• Assist the Study Medical Manager (SMM) throughout the entire clinical study lifecycle, from initiation to completion.

• Aid in the creation and evaluation of protocols, amendments, informed consent forms (ICFs), and medical data validation strategies.

• Prepare responses to medical and scientific inquiries from Health Authorities, Ethics Committees, study sites, and project teams.

• Help organize and oversee study committees, meetings, and associated documentation.

• Conduct medical reviews of patient profiles, narratives, listings, and safety data.

• Collaborate with Clinical Operations, Pharmacovigilance, Data Management, and Biostatistics to facilitate data review and ensure consistency checks.

• Evaluate essential study documents, including CRFs, validation plans, monitoring plans, and deviation listings.

• Contribute to interim and final clinical study reports, statistical outputs, and scientific publications.

• Assist with medical data assessments, case evaluations, and clinical study management activities across various therapeutic areas, including Immunology and Oncology.

• Support audit and inspection preparedness by maintaining accurate and compliant documentation.

⛳️ Requirements

• An advanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline.

• Experience in Clinical Development, Clinical Research, or as a Clinical Scientist within the pharmaceutical, biotech, or CRO sectors.

• Understanding of clinical trial processes and clinical development from study initiation to reporting.

• Experience in Oncology, Immunology, Inflammation, or other pertinent therapeutic areas.

• Strong knowledge of GCP, ICH guidelines, and regulations governing clinical research.

• Ability to review and interpret clinical, medical, and safety data effectively.

• Experience in contributing to protocols, clinical study reports, and scientific documentation.

• Excellent skills in cross-functional collaboration and stakeholder management.

• Proficiency in English, with strong capabilities in scientific and regulatory writing.

🏝️ Benefits

• Why join us?

• At Excelya, we merge a passion for science with teamwork enthusiasm to redefine excellence in healthcare.

• Here’s what sets us apart:

• We are a dynamic and ambitious healthcare company, uniting 900 Excelyates, all driven by the objective of becoming the leading mid-sized CRO in Europe while providing the best employee experience.

• Our "one-stop provider" service model—integrating full-service, functional service provider, and consulting—enables you to grow through diverse and stimulating projects. By partnering with top experts, you will contribute to the advancement of scientific, operational, and human knowledge, all aimed at enhancing the patient journey.

• Excelling with kindness means thriving in an environment that appreciates your natural talents, encourages boldness, challenges limits, and nurtures your potential, allowing you to fully engage in our collective mission.