Clinical Study 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.

We are seeking an experienced clinical study manager to join our Clinical Operations team  this role you will be responsible for delivering study start up and ongoing study management activities for your allocated clinical studies/projects. You will be a study management expert, ensuring that project requirements are gathered, communicated and actioned, and that study deliverables are achieved on time and to a high standard.

You will work alongside operational colleagues to report project financial details and achievement of milestones, responsible for appropriate reporting to support invoicing and reconciliation. As the clinical study manager you are the point person for the study and are crucial for successful delivery.

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

This is a hybrid role based out of the Cambridge or London office.

• Lead the delivery of assigned customer projects/clinical studies, from kick-off through to maintenance and close-out.
• Develop and maintain study plans, timelines, trackers and other study management documentation.
• Monitor study progress against agreed milestones, identifying risks, issues and dependencies at an early stage.
• Coordinate and lead study meetings, including preparing agendas and status updates, and ensure actions are documented and followed through.
• Work with customers to understand project goals and objectives, establishing the project requirements and expectations.
• Collaborate and communicate with all stakeholders (internal and external) at agreed and proactive frequencies.
• Support and work alongside clinical site managers and clinical data managers in the delivery of study milestones.
• Deliver study start-up activities, including leading Kick-off Meetings and creating, reviewing and releasing Key Study Documents and other required study documents.
• Own and manage project level change and risk management
• Monitor project financial milestones and work with Finance colleagues to support timelines invoicing and deliverable tracking.
• Deliver all study management activities to a high standard and in accordance with Qureight SOPs, Good Clinical Practice (GCP) guidelines, ISO
  27001 standards, data privacy regulations and all other applicable regulations
• Support general Clinical Operations process improvement

• Minimum of 2 years of clinical research experience ideally in an imaging Clinical Research Organisation or other clinical trial delivery environment
• Experience as a project manager or start-up specialist in clinical research is desirable, with a particular focus in lung and heart pharmaceutical trials
• Previous experience working with clinical trial imaging is highly desirable but not essential
• 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
• Knowledge of relevant regulatory,…