Senior Clinical Site Manager

About the role

About us 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. About the role A Senior 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 are experienced in site facing aspects of clinical trial delivery, and have significant experience in qualifiying, coordinating and managing clinical study sites globally. A positive and can-do attitude, alongside in-depth understanding of clinical study quality and regulatory standards is essential to the role. You would be responsible for working with... Lead site qualification activities for a number of concurrent clinical studies. Conduct Qureight site qualification activities for designated, including site evaluation, training and scanner qualification, to ensure timely onboarding of priority clinical study sites. Support and have oversight of more junior team members, providing mentorship and guidance in clinical study site qualification and management. Provide proactive and effective site facing communications to support clinical trial sites in completing site qualification activities before planned activation dates. Be responsible for site management activities post site qualification including query management. Be responsible for raising data queries with site staff and managing them through to completion. Be the point of contact for assigned clinical sites and appropriately escalate. Respond to and resolve inbound support requests in a timely and efficient manner in line with SOPs. Support other clinical site managers troubleshooting issues and act as a point of escalation where necessary 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. Provide proactive and effective Sponsor communications to ensure appropriate site status reporting is maintained for designated studies. When necessary, support image check (QC) processes for assigned projects, completing timely and accurate QC in line with SOPs. Maintain essential site facing documents, updating and sharing to relevant personel as needed. Have responsibility for designated Trial Master File and Site File documents. Take part in clinical project kick-off meetings where appropriate, and support bid defences. Step up to support the Study Manager as needed, chairing sponsor project meetings in their absence, reporting to sponsors etc Develop a strong working knowledge of CTs, enabling independent and appropriate troubleshooting of site qualification issues Step up to lead a small team of site managers as required Conduct work in accordance with Good Clinical Practice (GCP) guidelines and all relevant regulations, including ISO27001 standards and data privacy regulations. Be part of continuous improvement and operational efficiency by highlightling where improvements could be made and working to deliver them. 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: Minimum of 2-3 years of clinical trial site management experience, ideally in an imaging Clinical Research Organisation or Core Imaging Lab. Experience of clinical study site qualification and management for pharaceutical studies, e.g. site qualification, site training, support and site close out is essential Demonstrated experience with clinical imaging, e.g. CT or MRI is highly desirable. 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. Expert 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, e.g. 21 CFR Part 11, is desirable. Strong interpersonal skills with a high proficiency in written and verbal communications. Track record of working effectively and problem solving in a highly technical and innovative environment, demonst

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