Clinical Development Scientist, Computed Tomography

Job Description

Your role:

• Collect, appraise and analyze clinical data pertaining to a medical device.
• Write documentation, such as Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) Reports, supporting regulatory submission.
• Collaborate with internal (project owners, regulatory, study managers, statisticians, business leaders, post-market surveillance, risk management, etc.) and external (clinical consultants, subject matter experts, regulatory agencies) partners to ensure comprehensive analysis of clinical evidence.
• Ensure appropriate interpretation and dissemination of all evidence generated, including writing Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) Reports, and supporting the timely publication of study results.
• Create procedures and workflows related to the Clinical Development department.
• You're the right fit if:
• You have acquired 2+ years of experience in Clinical Affairs, Clinical Research, or a similar role within the Medical Device, Pharmaceutical, or Healthcare industry, with a proven track record of delivering clinical results on time, within budget, and in compliance with SOPs and regulatory requirements.
• You have a strong understanding of EU Medical Device Regulations, Good Clinical Practice (GCP), and ICH guidelines; experience with clinical investigation design, biostatistics, research methodologies, medical and scientific literature databases, and medical writing. Experience applying statistical methods to clinical data and proficiency with statistical software are preferred.