Senior Clinical Data Manager

Qureight; Cambridge, Greater London; Vor Ort; GBP 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Bonus plan

Private medical insurance

Life insurance

Cycle-to-work scheme

Contributory pension

Zusammenfassung

Qureight in the UK seeks a Senior Clinical Data Manager to own data quality and image management for commercial studies. You will be the main day-to-day contact for sponsors, lead UAT for the Imaging Platform, and ensure accurate, compliant data delivery.

You will mentor junior CDMs, shape processes, and work with data engineers to improve methods and tools. A can-do attitude and knowledge of GCP/ISO27001 are essential.

Qualifikationen

• Five years+ experience in clinical data management, ideally imaging-focused.
• Experience creating/managing imaging and data transfer specs with sponsors.
• Hands-on UAT experience for clinical/imaging systems.
• Sponsor-facing role with stakeholder relationship experience.
• Experience with clinical imaging data (CT/MRI in DICOM) and related data.
• Experience collaborating with technical teams using Jira.
• Knowledge of ICH GCP with recent training.
• Attention to detail and a can-do attitude.
• Comfort with command line tools; metadata tools are a plus.

Aufgaben

• Lead UAT for project-specific configurations of the Qureight Imaging Platform, including test planning and sign-off.
• Create and manage data and image transfer specifications with sponsors.
• Act as main sponsor contact for data and image management, ensuring clear communication.
• Perform image quality control (DICOM de-identification and screening) per instructions.
• Raise and track data queries and support staff in resolving them.
• Run data reconciliation and deliver transfer packages to sponsors and archival.
• Mentor junior Clinical Data Managers and share best practices.
• Contribute to continuous improvement via updated SOPs and work instructions.
• Collaborate with data engineers to refine methods and tools for clinical and image data.
• Deliver all activities on time and to a high standard per SOPs, GCP, ISO27001 and privacy regs.
• Build strong sponsor/colleague relationships with transparent communication.

Kenntnisse

Clinical data management

Sponsor liaison

UAT testing

DICOM

Jira

Tools

Jira

DICOM tools

PACS/VNA

AWS S3

Jobbeschreibung

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.

At Qureight, we're building a company where data management is treated as a core capability, not an afterthought. Data management supports every imaging endpoint and biomarker we work with, in respiratory and cardiac trials where accuracy matters and the science is still developing. If you want complex datasets, are enthusiastic about being part of a growing team and clinical data that genuinely informs trial outcomes, we'd love to meet you.

About the role

We are looking for a Senior Clinical Data Manager to own data quality and image management for our commercial clinical studies. You will be the main day-to-day contact for our sponsors. The role will entail leading user acceptance testing for the Qureight Imaging Platform; writing and managing data and image transfer specifications; and, making sure what we deliver is accurate, compliant and on time.

You will bring deep clinical data management experience from a clinical trials background, an imaging CRO or a core imaging lab. You will also mentor junior Clinical Data Managers and help shape the processes and tooling we are building in-house. A can-do attitude and a firm grasp of clinical data quality and regulatory standards are essential to the role.

What you will do

• Lead user acceptance testing (UAT) of project-specific configurations of the Qureight Imaging Platform, including test planning, execution, defect logging in Jira and sign-off.
• Create, agree and manage data and image transfer specifications with sponsors, working with project and study managers and giving technical input where needed.
• Act as the main point of contact for sponsors on data and image management, keeping communication clear, timely and consistent.
• Perform image (DICOM file) quality control activities (de-identification, visual screening etc.) In line with work instructions and best practice.
• Raise and track data queries and support internal and external staff to resolve them.
• Run data reconciliation and deliver image and data transfer packages to sponsors and archival.
• Mentor and support junior Clinical Data Managers, reviewing their work and sharing best practice.
• Be part of continuous improvement, writing and revising work instructions and SOPs to develop best working practices in clinical data management at Qureight.
• Work with data engineers to support them in developing new and improved methods and tools for managing clinical and image data at Qureight.
• Deliver all activities on time and to a high standard, working to Qureight SOPs, Good Clinical Practice (GCP), ISO27001 and applicable data privacy regulations.
• Build strong relationships with sponsor and colleagues across Qureight, keeping communication transparent and consistent.

Requirements

What we need

• Minimum of five years of clinical data management experience, ideally in an imaging Clinical Research Organisation.
• Proven experience creating and managing imaging and data transfer specifications with sponsors.
• Hands-on experience conducting UAT of clinical/EDC or imaging systems.
• Experience as a sponsor-facing point of contact, with demonstrated ability to cultivate and maintain key stakeholder relationships, both internally and externally.
• Demonstrated experience with clinical imaging related data (such as CT or MRI in DICOM formats) and/or other clinical variables.
• Experience working with technical teams and interacting via tools such as Jira.
• Knowledge of ICH Good Clinical Practice (GCP) with evidence of recent training.
• Track record of demonstrating a good attention to detail.
• Evidence of a can-do attitude with a tenacity and drive to achieve objectives.
• Comfortable working with data via command line tools and scripts is desirable.
• Experience with tools for inspecting and modifying metadata in DICOM imaging files is highly desirable but not essential.
• Knowledge of PACS/VNA/AWS S3 Data Storage.

Even better if you have

• A relevant degree.
• Experience mentoring or coaching colleagues, and experience working in a lean, fast-paced environment.
• Experience working within a Quality Management System (QMS), e.g. ISO 9001, ISO 13485 is desirable.
• Knowledge of relevant regulatory, compliance and industry standards, e.g. 21 CFR Part 11, and ISO27001 is desirable.

Benefits

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.