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Allen SpoldenPosted 29 months ago

Senior Clinical Data Manager

On-siteEscondido, California, United States

ContractSenior LevelBachelors DegreeSmall

Job Summary

Manage assigned study data activities from startup through closeout in accordance with SOPs, overseeing protocol reviews, database design, and EDC programming. Drive discrepancy resolution, data cleaning processes, and validation while ensuring regulatory compliance. Coordinate start-up, conduct, and finalization activities, participate in QA audit reviews, and lead User Acceptance Testing. Train and mentor junior team members in departmental procedures. Requires a BS/BA in health science with four years of pharmacy, clinical lab, or research experience.

Required Qualifications

  • BS/BA in health science, life science, information technology, or nursing
  • 4 years equivalent experience
  • demonstrated aptitude for the Clinical Data Manager role
  • Minimum of 4 years pharmacy, clinical lab, or research related experience, study or instruction
  • Working knowledge of EDC studies
  • Knowledge of clinical research including regulatory requirement, GCP/ICH Data Quality

Desired Qualifications

  • Experience working in CRO industry preferred

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