Manager, Clinical Data Review - Medical Devices (on-site)

Abbott seeks a Manager of Clinical Data Review to lead a team overseeing clinical study data management, database integrity, and regulatory compliance for medical devices. The role manages staff, CRF design, data quality processes, and cross-departmental reporting from on-site locations in California or Minnesota.

Responsibilities

• Hire, train, mentor, and manage clinical data management team members and evaluate performance
• Oversee data entry, cleaning, validation, and deliverables for clinical studies
• Design Case Report Forms and edit check specifications; ensure protocol compliance and data integrity
• Manage custom database reporting requests and provide clinical data outputs to internal departments
• Stay current on regulatory changes and train staff on requirements affecting clinical studies

Requirements

• Bachelor's degree in science-related field or equivalent education and experience
• Minimum 8 years progressively responsible experience in pharmaceutical or clinical data management
• Strong knowledge of clinical trial protocols, CRF design, and database management systems
• Leadership experience managing diverse teams and providing performance feedback
• Knowledge of FDA regulations and clinical data integrity requirements
• Proficiency with clinical database systems such as Oracle Clinical