Qureight
Qureight
Qureight este o companie din domeniul sănătății și biotehnologiei care aplică inteligența artificială în medicina de precizie și dezvoltarea medicamentelor. Platforma sa organizează și analizează date complexe din domeniul sănătății, combinând imagistica medicală, informațiile clinice, măsurătorile fiziologice și biomarkerii în seturi de date structurate și utilizabile. Qureight colaborează cu companii biofarmaceutice, organizații de cercetare contractuale, spitale și instituții medicale, concentrându-se pe bolile pulmonare și cardiace. Fluxurile de lucru și instrumentele de analiză a imaginilor bazate pe inteligență artificială sprijină cercetarea în domenii precum boala pulmonară interstițială, hipertensiunea pulmonară și cancerul pulmonar, ajutând echipele să identifice informații relevante din datele studiilor clinice și din datele din lumea reală. Activitatea companiei include analiza colaborativă a datelor, învățarea automată și tehnologii menite să susțină decizii mai bine fundamentate pe parcursul procesului de dezvoltare a medicamentelor.

Senior Clinical Data Manager, Imaging

Lead imaging data quality, sponsor transfers and user acceptance testing for Qureight’s AI-powered clinical trial platform. Oversee DICOM quality control and clinical data processes while supporting junior team members.

Descriere

  • Lead user acceptance testing for tailored Qureight Imaging Platform configurations, from test planning and execution to Jira defect tracking and approval.
  • Develop and manage data and image transfer specifications in agreement with sponsors.
  • Advise on technical matters alongside project and study managers.
  • Serve as the primary sponsor contact for data and image management.
  • Check DICOM image quality, including de-identification and visual review.
  • Log and monitor data queries, and help resolve them.
  • Reconcile data and prepare image and data transfer packages for sponsors and archiving.
  • Coach and support junior Clinical Data Managers.
  • Create and update work instructions and SOPs to support ongoing improvement.
  • Partner with data engineers to develop approaches and tools for managing clinical and image data.
  • Complete work on schedule and to a high standard, following Qureight SOPs, GCP, ISO 27001 and relevant data privacy regulations.
  • Build open, dependable working relationships with sponsors and Qureight colleagues.

Cerințe

  • At least five years of clinical data management experience; experience at an imaging CRO is preferred.
  • Demonstrated experience developing and managing sponsor data and imaging transfer specifications.
  • Practical experience conducting UAT for clinical, EDC or imaging systems.
  • Experience serving as a sponsor-facing contact and maintaining stakeholder relationships.
  • Experience with clinical imaging, including CT or MRI in DICOM format, and/or other clinical variables.
  • Experience collaborating with technical teams and using tools such as Jira.
  • Knowledge of ICH Good Clinical Practice (GCP), supported by recent training.
  • Strong attention to detail.
  • A proactive, persistent approach and drive to meet objectives.
  • Comfort using command-line tools and scripts to work with data is an advantage.
  • Experience reviewing and editing metadata in DICOM imaging files is highly desirable, but not essential.
  • Knowledge of PACS, VNA or AWS S3 data storage.
  • A relevant degree is advantageous.
  • Experience mentoring or coaching colleagues and working in a lean, fast-paced setting.
  • Experience working within a quality management system such as ISO 9001 or ISO 13485 is desirable.
  • Knowledge of regulatory, compliance and industry standards such as 21 CFR Part 11 and ISO 27001 is desirable.

Beneficii

  • Annual bonus plan.
  • Private medical insurance.
  • Life insurance.
  • Cycle-to-work scheme.
  • Contributory pension scheme.
  • Equity.
  • 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.

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