Senior Clinical Data Manager

Qureight; Cambridge, Greater London; Hybrid; GBP 65.000 - 95.000; Vollzeit

Benefits dieser Stelle

Annual bonus plan

Private medical insurance

Life insurance

Cycle-to-work scheme

Contributory pension

Equity

Zusammenfassung

Qureight in Cambridge is seeking 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 and lead UAT for the Qureight Imaging Platform.

You will mentor junior Clinical Data Managers and help shape processes and tooling, ensuring accuracy, compliance with GCP, ISO27001 and privacy standards, and timely delivery of data packages.

Qualifikationen

• Five+ years of clinical data management experience, ideally in imaging CROs or labs.
• Experience creating/managing imaging and data transfer specs with sponsors.
• Hands-on experience conducting UAT of clinical/EDC or imaging systems.
• Sponsor-facing contact with proven stakeholder relationship skills.
• Experience with imaging-related data (CT/MRI in DICOM) and related data workflows.

Aufgaben

• Lead UAT for project configurations of Qureight Imaging Platform; plan, execute, log defects, sign off.
• Create and manage data/image transfer specifications with sponsors and study managers.
• Act as main sponsor contact for data and image management with clear, timely communication.
• Perform image quality control (DICOM de-identification, visual screening) as per work instructions.
• Raise and track data queries; support staff to resolve them.
• Run data reconciliation and deliver transfer packages to sponsors and for archiving.
• Mentor junior Clinical Data Managers; review work and share best practices.
• Develop and revise SOPs/work instructions to improve clinical data management.
• Collaborate with data engineers to develop new tools for managing data and images.
• Deliver all activities on time and to high standard per GCP/ISO27001 and privacy rules.
• Build relationships with sponsors and colleagues across Qureight.

Kenntnisse

Clinical data management

Imaging data

UAT testing

Sponsor liaison

DICOM imaging

Jira

Regulatory standards

Ausbildung

Relevant degree

Tools

Jira

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.

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 ifyou 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.

What can you expect from us

• A comprehensive benefits package that includesan annual bonus plan, private medical insurance, life insurance, cycle-to-work scheme, and acontributory 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 familyleave
• 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.