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Clinical Data Manager

1 month 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:
  • Ensure the accuracy and consistency of clinical databases by reviewing data and identifying errors or inconsistencies.
  • Collaborate with project teams to prevent and resolve data issues.
  • Track outstanding issues and follow up until resolution.
  • Prepare and validate study metrics and ad hoc data listings as necessary.
  • Develop and maintain clinical data management documentation, including data management plans, data quality review plans, and user acceptance testing plans.
  • Facilitate data quality review meetings with cross-functional study team members to ensure ongoing review of trial data currency, quality, and completeness.
  • Meet milestone events such as database go-live, interim database freeze, database locks, and DSMB reviews.
  • Complete projects and tasks in a manner consistent with corporate goals and objectives.
  • Support Clinical Operations to evaluate EDC vendors and system functionality requirements for the study.
  • Represent Data Management on cross-functional projects.
  • Support the system vendor selection process to assess system capabilities with study team needs.
  • Program periodic study reports and training materials upon request.
  • Maintain the EDC database throughout the study, including mid-study changes.
Requirements:
  • Bachelor's degree in computer science or a related field.
  • 3+ years of relevant clinical data management experience using multiple EDC platforms.
  • Strong knowledge and experience of EDC systems, IRT, CTMS, eTMF, and ePRO.
  • Demonstrated knowledge of Microsoft Office Suite.
  • Well-versed in industry trends and emerging technologies supporting data collection.
  • Knowledge of FDA submission requirements and regulatory requirements such as ISO 14155, FDA regulations, and ICH Good Clinical Practice.