Associate Clinical Data Manager

Abbott seeks an Associate Clinical Data Manager for its Maple Grove, Minnesota location. The role involves managing clinical trial data throughout study lifecycle phases, including startup, conduct, and reporting, while collaborating with cross-functional teams on database systems and regulatory compliance.

Responsibilities

• Develop and translate clinical study requirements into technical eCRF specifications and database customizations
• Create data management documentation including Risk Mitigation Plans and Data Management Plans during study startup
• Design edit check specifications and conduct functional testing on databases and reporting systems
• Support data cleaning efforts and prepare datasets for regulatory submissions and biometrics teams
• Identify and resolve complex data and database structure issues through cross-functional collaboration

Requirements

• Experience with clinical data management and electronic case report forms (eCRF)
• Proficiency with SQL and database user interfaces for data analysis
• Knowledge of data validation, edit checks, and quality assurance processes
• Familiarity with FDA regulations and clinical database audit standards
• Ability to develop and maintain clinical database systems and specifications