Clinical Data Manager
TRACON Pharmaceuticals, Inc. - San Diego, CA

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General Summary:
The Clinical Data Manager is responsible for all data management tasks for multiple clinical studies from set up in electronic data management system (EDC) to database lock. Other responsibilities include:

Principal Duties and Responsibilities:
  • Review data and generate queries according to the data validation plan (DVP)
  • Maintain documentation relating to clinical data management including maintaining the data management portion of the Trial Master File
  • Contribute to DVP writing
  • Interface with site personnel, monitors and clinical operations staff to provide support related to data management (including EDC system issue resolution)
  • Assist in streamlining clinical data management procedures to create effective practices
  • Set up studies in EDC system
  • Train monitors and site personnel on EDC system
  • Import/export data and report generation from EDC system
  • Contribute to development of reports and plans (ie: clinical study reports/statistical analysis plans)
  • Coordinate with pharmacovigilance to review and generate queries related to serious adverse events
  • Correspond with and oversee data management vendors
  • Perform tasks according to company standard operating procedures (SOPs)
  • Bachelor’s degree or equivalent experience
  • Minimum of three years of direct clinical data management experience in the biotechnology or pharmaceutical industry
  • Working knowledge of Good Clinical Practices and ICH guidelines related to CDM
  • Exceptional organizational skills, highly adaptive in the face of changing priorities and practices
  • Effective written communication skills - 14 months ago - save job - block
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About this company
TRACON Pharmaceuticals, Inc. is a biopharmaceutical company that licenses, develops, and commercializes targeted therapies for cancer and...