Clinical Study Manager

Qureight; Town Of Cambridge; Hybrid; AUD 123,000 - 170,000; Full time

Benefits offered by this job

28 days’ holiday allowance

Equity in company

Private medical insurance

Contributory pension

Job summary

Qureight is seeking an experienced Clinical Study Manager to join our Clinical Operations team. You will deliver start-up and ongoing study management for allocated studies, ensuring requirements are gathered, communicated, and actioned, with timely, high-quality deliverables.

You will work with cross-functional teams to report financial milestones, support invoicing, and drive continuous process improvements in a hybrid Cambridge or London office environment.

Qualifications

• Minimum of 2 years of clinical research experience, imaging is a plus.
• Experience as a project manager or startup specialist in clinical research is desirable.
• Knowledge of ICH GCP and regulatory standards (21 CFR Part 11).
• Experience with QMS and quality documentation.

Responsibilities

• Lead delivery of assigned customer projects from kickoff to close-out.
• Develop and maintain study plans, timelines, and trackers.
• Monitor progress, risks, issues, and dependencies.
• Coordinate study meetings, prepare agendas and updates.
• Collaborate with customers to define goals and requirements.
• Communicate with internal and external stakeholders regularly.
• Support site managers and data managers to meet milestones.
• Oversee start-up activities and key study documents.
• Manage change and risk at the project level.
• Monitor financial milestones and support invoicing and reporting.
• Ensure compliance with SOPs, GCP, ISO27001, and privacy regs.

Skills

Project management

Stakeholder management

Clinical study delivery

GCP knowledge

QMS/Regulatory awareness

Analytical & reporting

Communication (written)

Problem solving

Team collaboration

Education

PM qualification or related

Degree in biomedical/technical field

Tools

Clinical trial imaging

ISO 9001/13485 knowledge

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.