Clinical Site Manager

Qureight’s mission is to accelerate clinical trials and ensure breakthroughs in lung and heart disease reach patients without delay. Our AI-powered data and imaging curation platform enables the analysis of clinical imaging and other healthcare data, helping our customers bring treatments to market, faster.

We’re looking for talented people who want their work to matter. With offices in Cambridge and London, you’ll join our multidisciplinary team of clinicians, scientists, and engineers. What unites us is our open culture, continuous learning mindset, and a shared mission to help biopharma run faster, smarter trials.

The Clinical Site Manager is responsible for managing clinical trial sites from site qualification to site management, including aspects of data management, image QC and query management, as part of the delivery of Qureight’s imaging CRO services. They ideally have experience in coordinating and managing clinical study sites globally or experience in a clinical trial setting generally.

A positive and can-do attitude, alongside an understanding of clinical study quality and regulatory standards is essential to the role.

• Conduct Qureight site qualification activities, including site evaluation, training and scanner qualification, to ensure timely onboarding of priority clinical study sites.
• Provide proactive and effective site facing communications to support clinical trial sites in completing site qualification activities before planned activation dates.
• Be responsible for designated site management activities post site qualification including query management.
• Be responsible for raising data queries with site staff and managing them through to completion, in collaboration with data management colleagues.
• Be the point of contact for assigned clinical sites and know when to escape for guidance and support.
• Respond to and resolve inbound support requests in a timely and efficient manner in line with SOPs.
• Communicate with all stakeholders in a professional and timely manner.
• Track and report project and site milestones and maintain relevant internal systems with project specific information.
• When necessary, support image check (QC) processes for assigned projects, completing timely and accurate QC in line with SOPs.
• Learn about and develop expertise in CT
• Step up to coordinate all site onboarding activities as site qualification lead for assigned projects as necessary.
• Maintain essential site facing documents, updating and sharing as needed.
• Take part in clinical project kick-off meetings where appropriate.
• Conduct work in accordance with Good Clinical Practice (GCP) guidelines and all relevant regulations, including ISO
  27001 standards and data privacy regulations.
• Be part of driving continuous improvement and operational efficiency by highlight ling where improvements could be made.
• Build strong relationships with all stakeholders (at site, with sponsors, with customers and within Qureight) maintaining transparent and consistent communication throughout.
• Support general Clinical Operations activities as needed.

What we need:

• Demonstrable experience in clinical trial site management
• Demonstrated experience with clinical imaging, e.g. CT or MRI is desirable but not essential.
• Strong organisational and time management skills with ability to prioritise tasks effectively.
• Demonstrated ability to cultivate and maintain key stakeholder relationships, both internally and externally.
• Knowledge of ICH Good Clinical Practice (GCP) with evidence of recent training.
• Experience working within a Quality Management System (QMS), e.g., ISO 9001, ISO 13485 is desirable.
• Knowledge of relevant regulatory, compliance and industry standards,…