Clinical Data Manager

2 days ago


Campbell, California, United States Katalyst Healthcares and Life Sciences Full time
Job Title: Clinical Data Manager

At Katalyst Healthcares and Life Sciences, we are seeking a highly skilled Clinical Data Manager to join our team. As a Clinical Data Manager, you will play a critical role in ensuring the accuracy and consistency of clinical databases.

Responsibilities:
  • Review and validate clinical data to ensure accuracy and consistency
  • Collaborate with cross-functional teams to identify and resolve data issues
  • Develop and maintain clinical data management documentation, including data management plans and user acceptance testing plans
  • Facilitate data quality review meetings with study team members
  • Meet milestone events, such as database go-live and interim database freeze
Requirements:
  • Bachelor's degree in computer science or related field
  • 3+ years of experience in clinical data management, preferably in a device, biopharmaceutical, or CRO setting
  • Strong knowledge of EDC systems, IRT, CTMS, eTMF, and ePRO
  • Demonstrated knowledge of Microsoft Office Suite and industry trends
  • Working knowledge of regulatory requirements, such as ISO 14155 and FDA regulations

We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for clinical data management, we encourage you to apply for this exciting opportunity.



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