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.
About the role
The Director, Clinical Data Manager is responsible for growing and managing a team of Clinical Data Managers, developing compliant clinical data and image management processes and ensuring the successful delivery of data management aspects of client clinical trials. Working with technical teams at Qureight and bringing experience of clinical data management tooling and best practice, you will drive the development of a standalone function but also directly deliver clinical data management services, from quality assurance to data reconciliation and transfer. You will be highly experienced in delivering clinical data management for clinical trials and in evolving or developing bespoke in‐house data management tooling and processes. A positive and can‐do attitude, alongside an in‐depth understanding of clinical study data quality and regulatory standards is essential for success in the role.
You will be responsible for...
* Develop and manage a team of Clinical Data Managers, responsible for line management, task allocation and group cohesion
* Be a key player in establishing clinical data management as a distinct function at Qureight, working to scale and grow data management capabilities, specific to delivering imaging CRO clinical study services.
* Set clear strategy and requirements for technical teams developing tooling to improve the efficiency of data management processes.
* Drive continuous improvement and operational efficiency, including revising work instructions and SOPs to develop best working practices, being an expert in the field
* Make appropriate decisions for clinical data management delivery, at individual project and departmental levels, in line with SOPs and with reference to Clinical Operations and Platform team/technical and senior leadership
* Collaborate with and work closely with other functional leads, particularly site management and platform teams, to drive innovation that matches Qureight's strategic and product roadmap goals for the delivery of Imaging CRO services
* When necessary, personally conduct clinical and imaging data management activities, including but not limited to image and data quality checks (QC), data reconciliation, data/image transfer specification documentation delivery, and data and image transfers.
* Ensure delivery of data management activities on time and to a high standard across the board
* Conduct work 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.
* Participate in Good Clinical Practice (GCP) audits as a subject matter expert.
* Build strong relationships with all stakeholders (with sponsors, with customers and within Qureight) maintaining transparent and consistent communication throughout.
* Support general Clinical Operations and Platform activities as needed.
What we need...
* A degree in a relevant scientific or technical area, is beneficial, especially in radiography or medical imaging science.
* Minimum of 5 years of clinical data management experience, ideally in an imaging Clinical Research Organisation or Core Imaging Lab.
* Deep knowledge and demonstrable experience in DICOM imaging formats, CT imaging metadata and the management of clinical variables is essential.
* Track record of working effectively and problem solving in a highly technical and innovative environment, demonstrating a good attention to detail. A genuine interest in data architecture and enabling data use downstream.
* Experience working with technical teams and interacting via tools such as Jira.
* Comfortable working with data via command line tools and scripts and demonstrated experience working with software teams.
* Strong project management skills with ability to prioritise tasks effectively and proactively.
* Demonstrated ability to cultivate and maintain key stakeholder relationships, both internally and externally.
* Strong interpersonal skills with a high proficiency in written and verbal communications.
* Expert knowledge of ICH Good Clinical Practice (GCP) with evidence of recent training.
* Evidence of a can‐do attitude with a tenacity and drive to achieve objectives.
Even better if...
* Line management and team leadership experience.
* Familiarity with clinical protocol conformance and CT scanner parameter harmonization.
* Previous experience as a clinical or research radiographer, with experience of CT (preferred), MRI, US.
* In‐depth knowledge of data formats/structures used in clinical trials and for archiving of clinical trial datasets.
* Knowledge of PACS/VNA/AWS S3 Data Storage.
* Experience working within a Quality Management System (QMS), e.g., ISO 9001, ISO 13485, GxP.
* Knowledge of relevant regulatory, compliance and industry standards, e.g. 21 CFR Part 11, and ISO27001.
What can you expect from us
* 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 Employment
If you have any queries, please contact HR@qureight.com. 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.
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