Senior Clinical Study Manager

Senior Clinical Study Manager Cycle Company: Cycle Pharmaceuticals Ltd Position Summary: This full-time position is within the Research and Development department in our Cambridge office on a hybrid basis (minimum 3 days in the office). Do you want to make a meaningful difference in rare disease research? At Cycle Pharmaceuticals, we’re expanding our Research and Development team and now recruiting for a hands-on Senior Clinical Study Manager to manage the operational delivery of Phase 3 clinical trials and Phase 4 post-approval studies across rare diseases, including studies undertaken to meet FDA post-marketing requirements and commitments. Reporting to the Associate Director of Clinical Operations, you’ll take ownership of assigned studies from feasibility through to final clinical study report, ensuring delivery to agreed timelines, budgets and the highest standards of quality and regulatory compliance. This is an opportunity to take on broad responsibility in a growing organisation, combining independent ownership, cross-functional collaboration and the opportunity to help advance research in rare diseases. Our Company At Cycle, we believe that Every Single Patient Matters . This is at the heart of why we work and were looking for people to join our team who share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen. Our growing portfolio now covers oncology, haematology, neurology and rare metabolic genetic conditions where we improve existing drugs, repurpose them for new uses and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice. Headquartered in Cambridge, UK, with a significant US presence, Cycle has scaled rapidly and was named one of the UK’s fastest-growing private companies by The Sunday Times (Sunday Times 100 2024 & Sunday Times 100 Tech 2025). If you want to know more about what we do then, why not check out our website and take a look at some of our patient stories: Patient Stories - Cycle Pharma What you’ll be doing in this role: • Delivery of assigned Phase 3 clinical studies from feasibility through to database lock and final clinical study report, managing timelines, budgets, risks and quality. • Lead feasibility, country and site selection and develop recruitment and retention strategies tailored to small and pediatric populations, including patient-centric and decentralised approaches where appropriate. • Coordinate clinical supply planning, randomisation, interim analyses, data monitoring committee activities and adaptive design decision points in collaboration with relevant teams. • Support with operational delivery of post-approval studies, including FDA post-marketing requirements and commitments, registries, observational studies, real-world evidence and open-label extensions, ensuring key regulatory milestones are met. • Support partner selection and contracting and vendor performance, monitor KPIs and study expenditure. • Ensure studies comply with applicable GCP and regulatory requirements, oversee regulatory and ethics submissions, maintain the electronic Trial Master File (eTMF), and support audits, inspections and CAPA follow-up. • Build effective relationships with investigators, specialist centres and patient advocacy groups. • Proactively identify and mitigate operational risks and issues, escalating significant concerns and implementing appropriate corrective actions. • Contribute to departmental budget planning, resource forecasting and prioritisation to support clinical operations strategy and efficient study delivery. • Improve clinical operations proce