Clinical Operations Manager / Senior Clinical Operations Manager – Phase I/IIAntibody Programme

RQ Bio is a UK virology biotech developing long-acting monoclonal antibodies for influenza. We're hiring a Clinical Operations Manager or Senior Manager to take real operational ownership of our Phase I study, then Phase II, and to help plan Phase III as the programme moves forward. You'll be part of a small clinical team, close to the people making decisions, and you'll shape how RQ Bio runs its trials. The role grows as the programme does. The opportunity This is a hands-on role in a lean sponsor team. You won't be one function among many: you'll be the person who makes our clinical studies happen. You'll work closely with our CROs and vendors, hold them to account, and build the processes, documents and habits that get a young clinical programme ready for inspection. If you've run studies in a large organisation and want more breadth and influence, or you already work in biotech and want to grow with a programme through to late-stage development, this role offers both. What you will own Day-to-day delivery of our Phase I study, then Phase II, from start-up through to close-out Oversight of CROs and vendors: performance, deliverables, timelines and budgets Study plans, risk logs and budget tracking. You'll raise problems early and bring options with them eTMF/TMF quality and completeness, keeping the study ready for inspection at all times Risk-based quality management in line with GCP and ICH E6(R3) Study documentation and SOPs: writing, reviewing and improving them as the clinical function grows Input into Phase III planning as the programme matures What RQ Bio is looking for Sponsor-side clinical operations or study management experience, including independently managing Phase I and/or Phase II trials Typically 5–8+ years of hands-on study or clinical project management. What matters is time spent owning studies, not total years in clinical research A track record of managing CROs and vendors against timelines, budgets, risks and deliverables Experience on global or multi-country studies Strong working knowledge of GCP, ICH E6(R3), eTMF/TMF, RBQM and inspection readiness Experience in biotech or another lean sponsor setting where your role went well beyond a narrow remit. We'll consider large-pharma backgrounds where you can show real hands-on study ownership and breadth Good judgement and clear, proactive communication with internal stakeholders and external partnersWillingness to roll your sleeves up. In a small biotech there's no department to hand things off to: one day you're shaping study strategy, the next you're chasing a vendor deliverable or tidying the TMF yourself Infectious disease, influenza, vaccines, biologics or monoclonal antibodies. Helpful, but strong study ownership matters more than therapeutic area Contributing to late-phase or Phase III planning Setting up or improving clinical SOPs and quality processes in an early-stage company Working arrangements Hybrid and UK-based, aligned to London, with roughly one day a week in the office Occasional meetings in Cambridge #J-18808-Ljbffr