Clinical Study Manager in Cambridge

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.

About The Role

We are seeking an experienced clinical study manager to join our Clinical Operations team at Qureight. In 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.

You will be responsible for:

• Being the key player in the delivery of customer projects/clinical studies, the Qureight expert on project specifics.
• Managing and executing assigned clinical studies/commercial projects from kick‑off to study management phase through close‑out.
• Setting up, maintaining and reporting from a clinical study project plan.
• Working with customers to understand project goals and objectives, establishing the project requirements and expectations.
• Collaborating and communicating with all stakeholders (internal and external) at agreed and proactive frequencies.
• Delivering study start‑up activities with close attention to detail and raising any issues or changes promptly for resolution.
• Creating, reviewing and releasing Key Study Documents and all other study documentation, storing and sharing in appropriate internal systems.
• Supporting and working alongside clinical site managers and clinical data managers in the delivery of study milestones.
• Working with Relationship Managers to resolve customer level / Sponsor issues efficiently.
• Owning and managing project level change and risk management, for example implementing documentation up‑versioning and mitigating study specific risks.
• Being responsible for financial milestone reporting, working with finance colleagues to ensure timely invoicing, reconciliation and deliverable tracking.
• Delivering all study management activities to a high standard and in line with Qureight SOPs and in accordance with Good Clinical Practice (GCP) guidelines and all relevant regulations, including ISO27001 standards and data privacy regulations.
• Playing a driving role in maintaining Qureight study management processes, looking for and delivering process improvement opportunities throughout the study lifecycle.
• Supporting general Clinical Operations process improvement.

Requirements

• 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, compliance and industry standards, e.g. 21 CFR Part 11.
• 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, demonstrating a good attention to detail.
• Evidence of a can‑do attitude with tenacity and drive to achieve objectives.
• Experience of, or formal qualification in, project management.

Benefits

• A comprehensive benefits package that includes an annual bonus plan, private medical insurance, life insurance, and a contributory pension scheme.
• 25 days annual leave, plus bank holidays and enhanced maternity leave.
• A diverse work environment that brings together experts in many fields, including software engineering, devops, data science, machine learning, quality assurance, regulatory affairs, and clinical operations.

Equal Opportunity

Everyone is welcome at Qureight. We are an equal opportunities employer and encourage applications from all suitably qualified candidates regardless of age, disability, ethnicity, sex, gender reassignment, religion or belief, sexual orientation, marriage and civil partnership, or pregnancy and maternity. Women and other underrepresented groups may be less likely to apply unless they meet all or nearly all of the requirements. If this applies to you, we still encourage you to apply – you may be a great fit, even if you don't meet every qualification. If you require any adjustments to the application or selection process, please let us know. We will be happy to support you.