Clinical Scientist – Rare Disease

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Excelya

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Excelya is a leading global Contract Research Organization (CRO) focused on advancing healthcare through innovative solutions and expert guidance. With a presence in 28 countries, Excelya supports biotech, pharmaceutical, and medical device companies by offering full-service, functional service provider (FSP), and resourcing solutions across a broad spectrum of therapeutic areas. The company's unique business model emphasizes collaboration and flexible services, enabling clients to deliver life-changing therapies effectively.

📋 Description

• Support the Study Medical Manager (SMM) throughout the clinical study lifecycle, from start-up to close-out. • Contribute to the development and review of protocols, amendments, informed consent forms (ICFs), and medical data validation plans. • Draft responses to medical and scientific queries from Health Authorities, Ethics Committees, study sites, and project teams. • Support the organization and management of study committees, meetings, and related documentation. • Perform medical review of patient profiles, narratives, listings, and safety data. • Collaborate with Clinical Operations, Pharmacovigilance, Data Management, and Biostatistics to support data review and consistency checks. • Review key study documents, including CRFs, validation plans, monitoring plans, and deviation listings. • Contribute to interim and final clinical study reports, statistical outputs, and scientific publications. • Support medical data review, case assessments, and clinical study management activities across therapeutic areas, including Immunology and Oncology. • Assist with audit and inspection readiness by ensuring accurate and compliant documentation.

🎯 Requirements

• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific field. • Experience in Clinical Development, Clinical Research, or a Clinical Scientist role within the pharmaceutical, biotech, or CRO industry. • Knowledge of clinical trial processes and clinical development from study start-up to reporting. • Experience in Oncology, Immunology, Inflammation, or other relevant therapeutic areas. • Strong understanding of GCP, ICH guidelines, and clinical research regulations. • Ability to review and interpret clinical, medical, and safety data. • Experience contributing to protocols, clinical study reports, and scientific documents. • Strong cross-functional collaboration and stakeholder management skills. • Fluent in English, with strong scientific and regulatory writing capabilities.

🏖️ Benefits

• Why join us? • At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare. • Here's what makes us unique: • We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience. • Our "one-stop provider" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey. • Excelling with kindness means evolving in an environment that values ​​your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.