Corin Group is a global orthopaedics innovation business, which is head quartered in Cirencester, Gloucestershire! Across 7 units in Love Lane, we manufacture knee and hip implants that are then shipped around the world to provide patients the best possible outcomes! With over 400 employees, we are focused on precision, quality, and customer demand to ensure that we are producing a high quality product at all times. Due to the exciting growth of Corin, we are now looking to expand our Clinical Affairs Team to be able to continue to deliver to meet the worldwide demand. We are seeking a highly skilled and detail-oriented Clinical Data Management and Analysis Specialist to join our team. This role will play a key part in supporting global clinical studies, contributing to all aspects of the data management and analysis process—from study start-up through to database lock and post-market activities. You will work cross-functionally to ensure all clinical data processes meet regulatory standards and contribute to the successful delivery of pre- and post-market clinical evidence for medical devices. What you'll do Support global clinical study data management activities from start-up to database lock and regulatory submission support Design, implement, validate, and maintain Electronic Data Capture (EDC) systems Contribute to study timelines and ensure key milestones and deliverables are met Review and input into clinical protocols, statistical analysis plans, and clinical study reports Develop and maintain study documentation including CRFs, Data Management Plans, and Data Handling Guidelines Perform programming tasks (e.g. data transfers, data integration, report generation, and statistical outputs) using tools such as R, SQL, Python, or VBA Prepare and analyse clinical datasets (e.g. lab data, imaging, adverse events, and patient-reported outcomes) Collaborate with internal teams and external vendors, ensuring high-quality data deliverables Identify and communicate risks to timelines, quality, and budgets Support audits and ensure compliance with regulatory standards and internal SOPs Contribute to process improvements and development within the Data Management function Compliance & Standards Ensure adherence to ISO 14155 (Good Clinical Practice) and FDA 21 CFR Part 11 Support compliance with ISO 13485 QMS and FDA 21 CFR Part 820 (GMP) Contribute to CAPA processes in line with company objectives and SOPs About You We are looking for someone who is analytical, adaptable, and proactive, with a passion for clinical data and continuous improvement. Essential: Bachelor’s degree in Computer Science, Statistics, Biostatistics, Mathematics, or related discipline (or equivalent experience) Minimum 2 years’ experience in clinical data management within medical device studies Strong programming skills (e.g. R, SQL, Python, VBA) Advanced Microsoft Excel skills Solid understanding of clinical study processes, EDC systems, and data reporting Excellent attention to detail and problem-solving ability Strong written and verbal communication skills Ability to manage multiple priorities in a fast-paced environment Desirable: Experience working with global clinical studies Vendor management experience What We Offer Competitive salary and benefits package Opportunity to work on innovative global clinical studies Collaborative and supportive team environment Ongoing professional development and training Career progression opportunities Apply Now If you are looking to take the next step in your clinical data career and contribute to impactful medical device research, we would love to hear from you.
