Manager, Clinical Data Review (on-site) Job at Abbott, Maple Grove, MN

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  • Abbott
  • Maple Grove, MN

Job Description

Abbott seeks a Manager, Clinical Data Review to lead a data management team at the Maple Grove, Minnesota site. The role oversees clinical trial data integrity, Case Report Form design, database management, and staff development while ensuring regulatory compliance.

Responsibilities

  • Hire, develop, and manage clinical data management staff with coaching and performance feedback
  • Oversee data entry, cleaning, deliverables, and clinical database integrity activities
  • Manage CRF development, edit specifications, and Risk-Based Quality Management implementation
  • Monitor operational and quality metrics, identify improvement opportunities, and implement corrective actions
  • Ensure team compliance with FDA regulations, protocols, and company quality management systems

Requirements

  • Experience managing clinical data management teams and staff
  • Knowledge of Case Report Form design and clinical database systems
  • Understanding of FDA regulations and clinical trial protocol requirements
  • Proficiency with data quality assurance and Risk-Based Quality Management practices
  • Experience implementing data integrity processes and edit check specifications
  • Strong leadership and performance management capabilities

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