Clinical Operations Manager / Senior Clinical Operations Manager – Phase I/II Antibody Programme

RQ Biotechnology Ltd.; Greater London; Hybrid; GBP 85,000 - 120,000; Full time

Job summary

RQ Bio is a UK virology biotech developing long-acting monoclonal antibodies for influenza. We are hiring a Clinical Operations Manager or Senior Manager to own our Phase I study, then Phase II, and help plan Phase III as the programme evolves.

You will work closely with CROs and vendors and shape how trials run in a lean sponsor team. This hands-on role requires strong ownership of studies, proactive problem solving, and a readiness to grow with the programme across early- to late-stage

Qualifications

• Experience leading sponsor-side clinical operations for Phase I/II trials.
• Proven track record managing CROs and vendors to timelines and budgets.
• Strong knowledge of GCP, ICH E6(R3), eTMF/TMF and inspection readiness.

Responsibilities

• Deliver Phase I study from start-up to close-out and support Phase II.
• Oversee CROs and vendors, monitoring performance, deliverables and budgets.
• Develop and maintain study plans, risk logs and budget tracking; escalate issues with options.

Skills

Phase I/II study ownership

Vendor/CRO management

GCP & ICH E6(R3) knowledge

Global/multi-country studies

Hands-on study ownership

Job description

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