Clinical Data Manager

Gefunden in: Talent DE 2A C2 - vor 2 Wochen


Munich, Deutschland Meet Vollzeit

Summary:


Our client seeks a Clinical Data Manager to join their Clinical Operations Department, supporting either home-based or office-based work in Germany. The ideal candidate will possess strong analytical skills, an action-oriented approach, and excellent organization and communication abilities.


Responsibilities:



  • Supervise and manage data management activities, providing support to clinical trial team members.
  • Oversee the development, implementation, and change management of clinical data management activities and systems.
  • Ensure compliance with CDISC standards and participate in defining and implementing eCRF / IRT standards.
  • Review clinical trial documents and develop and maintain SOPs, guidance documents, and training materials.
  • Archive clinical trial databases and related documents.


Requirements:


  • Advanced degree in Life Sciences or Computer Sciences, or equivalent experience.
  • Minimum 5 years of data management experience in the pharmaceutical/biotechnology industry.
  • Database programming knowledge is a huge plus
  • Proficiency with EDC and IRT systems, CDISC (SDTM) expertise, and experience in data management project management.
  • Expertise in SAS programming / R programming and knowledge of medical terminology, coding, and SAE reconciliation preferred.
  • Thorough understanding of ICH-GCP, FDA, and EMA regulations.


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