Senior Clinical Study Manager

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.

We are seeking an experienced Senior Clinical Study Manager to join our Clinical Operations team  this role you will lead study start up and ongoing study management activities for your allocated studies/projects, ensuring they are delivered on time and to a high standard.

As a study management lead, you will serve as the primary point of contact for both customers and internal teams. You will write key study documents, lead customer meetings, and proactively manage risks and issues. Working closely with operational colleagues you will report project financial details and achievement of milestones to support invoicing and reconciliation.

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.

• Take overall responsibility for the operational delivery of assigned customer projects/clinical studies from initiation through to close out, ensuring delivery against agreed scope and timelines.
• Be the Qureight subject matter expert for assigned studies, maintaining oversight of study-specific requirements, deliverables and operational performance.
• Develop and maintain study plans, timelines, trackers and other study management documentation.
• Support and work alongside clinical site managers and clinical data managers in the delivery of study milestones.
• Collaborate effectively with internal and external stakeholders, building a strong working relationship with them.
• Act as a senior point of contact and trusted partner for assigned clients.
• Establish and maintain strong, long-term client relationships.
• Lead client meetings, prepare agendas and status updates, and ensure actions are documented and followed through.
• Maintain comprehensive oversight of study risks, issues and dependencies.
• Anticipate operational challenges and proactively develop mitigation and contingency strategies.
• 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, assessing the impact on scope, timeline, resources and financial performance, working closely with Business Development and other functions as required.
• Maintain oversight of study financial milestones and contribute to financial forecasting, invoicing, reconciliation 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.
• Play a driving role in developing and maintaining Qureight study management processes, looking for and delivering process improvement opportunities throughout the study lifecycle. This includes writing and reviewing SOPs.
• Support and have oversight of more junior team members, providing mentorship and guidance.

• Minimum of 4 years of clinical research experience ideally in an imaging Clinical Research Organisation or…