Clinical Study Manager

Qureight Ltd; Cambridge; Hybrid; GBP 50,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Private medical insurance

Life insurance

Cycle-to-work scheme

Contributory pension

Job summary

Qureight Ltd, based in the UK with offices in Cambridge and London, seeks an experienced Clinical Study Manager to join the Clinical Operations team. You will lead start-up and ongoing management of allocated studies, ensuring deliverables meet high standards and regulatory expectations.

You will develop study plans, track milestones, report financial details for invoicing, and work with internal and external stakeholders to drive successful delivery.

Qualifications

• 2+ years of clinical research experience, ideally in imaging CR environment.
• Experience as a project manager or start-up specialist in clinical research is desirable, with focus on lung and heart trials.
• Exposure to clinical trial imaging is highly desirable but not essential.
• Proven ability to cultivate and maintain key stakeholder relationships.
• Knowledge of ICH GCP with recent training.
• Experience within a QMS (ISO 9001, ISO 13485).
• Familiarity with regulatory standards e.g. 21 CFR Part 11.
• Strong interpersonal and written/verbal communication skills.
• Track record of solving problems in technical, innovative settings.
• Evidence of a can-do attitude and drive to achieve objectives.
• Experience or qualification in project management.

Responsibilities

• Lead delivery of assigned customer projects/clinical studies from kick-off through maintenance and close-out.
• Develop and maintain study plans, timelines, trackers and other study docs.
• Monitor progress against milestones; identify risks and dependencies early.
• Coordinate and lead study meetings with agendas and status updates.
• Engage with customers to define project goals and requirements.
• Collaborate with internal and external stakeholders at planned frequencies.
• Support clinical site managers and data managers to meet milestones.
• Deliver start-up activities including Kick-off Meetings and key study documents.
• Own change and risk management at the project level.
• Track financial milestones and coordinate with Finance for invoicing.
• Ensure all activities align with SOPs, GCP, ISO27001, data privacy, and regulations.
• Support Clinical Operations process improvements.

Skills

Clinical Study Management

Project Management

Communication skills

Attention to detail

Education

Degree in a relevant scientific field

Job description

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

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.

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

What you will do

• 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, ISO27001 standards, data privacy regulations and all other applicable regulations.
• Support general Clinical Operations process improvement.

What we need

• 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 a tenacity and drive to achieve objectives.
• Experience of, or formal qualification in, project management

Even better if

• A degree in a relevant scientific or technical area, e.g. biomedical science, is beneficial, but not essential.

What can you expect from us

• A comprehensive benefits package that includes an annual bonus plan, private medical insurance, life insurance, cycle-to-work scheme, and a contributory pension scheme.
• Equity, so that our team can share in the long-term success of Qureight.
• 28 days’ holiday allowance, 25 days’ annual leave and 3 additional company days between Christmas and New Year, plus bank holidays and enhanced family 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.

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 for a role 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. We’d love to hear from you.

If you require any adjustments to the application or selection process, please let us know. We will be happy to support you.