Senior Clinical Data Manager/Principal Clinical Data Manager

hace 1 semana

Alcobendas, Madrid, España Precision Medicine Group A tiempo completo
Job Summary

The Senior Clinical Data Manager/Principal Clinical Data Manager is a key member of our team, responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock. This role requires strong leadership and organizational skills, as well as expertise in clinical database management systems.

Key Responsibilities
  • Manage clinical trial data management processes, including data entry, quality control, and database development.
  • Oversee project timelines, ensuring that clinical data management deadlines are met with quality.
  • Develop and maintain data management documentation, including CRF specifications and edit check specifications.
  • Train clinical research personnel on study-specific CRF, EDC, and other project-related items.
  • Review and query clinical trial data according to the Data Management Plan.
  • Perform line listing data review and run patient and study level status and metric reporting.
  • Liaise with third-party vendors, including external data and EDC vendors, to support project timelines and data-related deliverables.
Requirements
  • Bachelor's degree and/or related experience.
  • Minimum 2 years of experience as a Lead Data Manager for a Clinical Research Organisation.
  • Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
  • Excellent organizational and communication skills.
  • Professional use of the English language, both written and oral.
  • Experience in utilizing various clinical database management systems.
  • Broad knowledge of drug, device, and/or biologic development and effective data management practices.
Preferred Qualifications
  • Experience in a clinical, scientific, or healthcare discipline.
  • Dictionary medical coding (MedDRA and WHODrug).
  • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).
  • Oncology and/or Orphan Drug therapeutic experience.

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