Qureight is a healthcare and biotechnology company applying artificial intelligence to precision medicine and drug development. Its platform curates and analyzes complex healthcare data, combining medical imaging, clinical information, physiological measurements, and biomarkers into structured, usable datasets. Qureight works with biopharmaceutical companies, contract research organizations, hospitals, and healthcare institutions, with a focus on lung and heart diseases. Its AI-enabled workflows and image-analysis tools support research in areas including interstitial lung disease, pulmonary hypertension, and lung cancer, helping teams identify insights from clinical-trial and real-world data. The company’s work spans collaborative data analysis, machine learning, and technology designed to support more informed decisions throughout the drug-development process.
Senior Clinical Study Manager – Cambridge Hybrid
Lead regulated clinical studies and customer projects for Qureight’s AI-powered healthcare imaging platform. Manage study delivery, client relationships, risks, documentation, finances, and cross-functional teams from Cambridge or London.
Description
- Manage assigned customer projects and clinical studies from initiation through closeout.
- Deliver work within agreed scope and timelines.
- Provide subject-matter expertise for assigned studies.
- Monitor study requirements, deliverables, and operational performance.
- Create and maintain study plans, schedules, trackers, and management records.
- Help clinical site and data managers achieve study milestones.
- Coordinate effectively with internal and external stakeholders.
- Serve as the senior contact and trusted partner for assigned clients.
- Build and sustain long-term client relationships.
- Lead client meetings, prepare agendas and status reports, and monitor follow-up actions.
- Manage study risks, issues, and dependencies.
- Create mitigation and contingency plans.
- Lead study start-up work, including kick-off meetings and the preparation, review, and release of key documents.
- Control project changes and evaluate their effects on scope, schedules, resources, and financial performance.
- Monitor financial milestones and support forecasting, invoicing, reconciliation, and deliverable tracking.
- Perform work in line with Qureight SOPs, GCP, ISO 27001, data privacy requirements, and other applicable regulations.
- Improve study management processes and draft or review SOPs.
- Coach and support junior team members.
Requirements
- At least four years of clinical research experience, preferably within an imaging CRO or another clinical trial delivery setting.
- Professional experience as a clinical research project manager or study manager is required.
- Experience with lung and heart pharmaceutical trials is preferred.
- Clinical trial imaging experience is highly desirable but not required.
- Ability to develop and sustain important relationships with internal and external stakeholders.
- Strong knowledge of ICH Good Clinical Practice, supported by recent training.
- Experience operating within a quality management system such as ISO 9001 or ISO 13485.
- Understanding of applicable regulatory, compliance, and industry standards, including 21 CFR Part 11.
- Excellent interpersonal skills and strong written and verbal communication abilities.
- Demonstrated ability to work effectively and solve problems in a highly technical, innovative environment.
- High level of attention to detail.
- Determination, initiative, and persistence in achieving objectives.
- Project management experience or a formal project management qualification.
- A relevant scientific or technical degree is advantageous but not required.
Benefits
- Annual bonus scheme.
- Private medical insurance.
- Life insurance.
- Cycle-to-work scheme.
- Contributory pension plan.
- Equity participation.
- 28-day holiday allowance.
- 25 days of annual leave.
- Three additional company days between Christmas and New Year.
- Bank holidays.
- Enhanced family leave.
- A diverse workplace with multidisciplinary expertise.