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 an advanced degree is preferred. Significant clinical operations experience within the pharmaceutical, biotechnology or CRO industry, including operational leadership of Phase 3 clinical studies. Experience delivering studies in rare diseases, metabolic conditions or paediatric populations is strongly preferred. Experience managing post-approval studies, including FDA post-marketing requirement and commitment studies, open-label extensions, registries or observational studies, is strongly preferred. Strong experience working with US clinical sites and FDA requirements and familiarity with FDA Bioresearch Monitoring inspections is an advantage. Proven ability to oversee CROs and vendors, manage study budgets and maintain high-quality electronic Trial Master Files (eTMFs). Experience with hybrid or decentralised trial approaches, including home nursing and direct-to-patient supply, is desirable. Strong working knowledge of ICH-GCP, including E6(R3), and applicable FDA, MHRA and EMA requirements. Excellent organisational, analytical and project management skills, with the ability to manage competing priorities, solve problems independently and drive delivery. Strong communication and stakeholder management skills, with the confidence to work effectively across cross-functional teams and external partners. Proactive, hands-on and decisive, with a practical, solutions-focused mindset and a willingness to travel, including internationally to the US. What can we offer to you: In addition to being part of a great team and doing things that will make a real difference to patients’s lives, you will enjoy all the benefits that brings: Competitive salary based on experience A collaborative high performing work environment Performance based bonus Opportunity to join a fast growing and ambitious business Company pension scheme 100% employer paid membership for Private Health Insurance Life and Critical Illness Insurance Corporate Gym membership Regular team building events and an agile working environment Diversity and Inclusion statement: At Cycle Pharmaceuticals, we are committed to creating an inclusive, respectful, positive and diverse workplace. We do not discriminate on the basis of race, colour, religion, gender, age, disability, or any other protected characteristic. We actively support and embrace diversity, and we are working to build a team that reflects a wide range of backgrounds and perspectives. We value your unique contributions and encourage you to join us in shaping a more inclusive future. If you require any reasonable adjustments - whether during the application process or in the workplace - we will be happy to support your needs. At Cycle, equality, inclusion and respect are at the core of everything we do. We fully comply with all applicable employment laws, including those related to non-discrimination, work authorization, and employment eligibility verification.