Clinical Data Systems Analyst — Lead Data for Trials

PowerToFly; North Chicago (IL); Sur place; USD 110 000 - 140 000; Plein temps

Résumé du poste

AbbVie is seeking a data management professional to support clinical research trials in a regulated environment. The role emphasizes data quality systems, protocol-driven data collection, and collaboration with cross-functional teams to ensure compliant data management throughout studies.

The candidate will mentor staff and apply GCP/GCDMP knowledge to ensure high-quality data for regulatory submissions, while maintaining adherence to SOPs and industry standards.

Qualifications

• Bachelor's degree required; clinical research experience preferred.
• Minimum 3 years in clinical research.
• 3 years' experience with clinical data systems.
• 1–2 years supervisory or leadership experience.
• Ability to work independently with minimal guidance.
• Strong knowledge of GCP, GCDMP, SOPs and pharma regulations.

Responsabilités

• Ensure compliance with applicable corporate and divisional policies.
• Implement and maintain the data quality system.
• Review protocols and provide comments on study setup and data collection.
• Ensure data collection/management systems reflect protocol requirements.
• Ensure quality and performance metrics are captured accurately.
• Assist with documentation, testing, validation and implementation of data management systems.
• Mentor and train staff on data management and GCP/GCDMP.

Connaissances

Clinical Research

Data Management Systems

Leadership

GCP/GCDMP knowledge

Pharma regulations

Formation

Bachelor's Degree

Outils

EDC systems

Clinical Data Management Systems

Description du poste

AbbVie is seeking a data management professional to support clinical research trials in a regulated environment. The role emphasizes data quality systems, protocol-driven data collection, and collaboration with cross-functional teams to ensure compliant data management throughout studies.

The candidate will mentor staff and apply GCP/GCDMP knowledge to ensure high-quality data for regulatory submissions, while maintaining adherence to SOPs and industry standards.