Clinical Data Systems Analyst - Lead Quality & Compliance

ABBVIE; North Chicago (IL); On-site; USD 66,000 - 126,000; Full time

Benefits offered by this job

Benefits package

401(k)

Paid time off

Job summary

AbbVie in North Chicago, IL is seeking a Clinical Data Manager to support the conduct of clinical research trials in compliance with regulatory and company requirements. You will ensure data collection and transmission systems meet the needs of investigators, staff, and sponsors.

The role includes designing data collection systems reflecting protocols, maintaining data quality, and mentoring staff on GCP, GCDMP, and SOPs. A Bachelor’s degree and several years in clinical research are required.

Qualifications

• Bachelor’s Degree.
• 3 years in Clinical Research.
• 3 years' experience with clinical research data systems.
• 1-2 years supervisory or leadership role.
• Electronic source systems experience preferred.
• Must understand GXP, GCDMP, and SOPs; able to work independently and in a team.

Responsibilities

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Implement and maintain the effectiveness of the data quality system.
• Review Draft Protocols and provide comments on study setup, data collection and transmission, and workflow and implications for external client groups (Sponsor/vendor).
• Ensure the design of clinical data collection and management systems used by the ACPRU in the conduct of clinical research trials accurately reflect the protocol requirements and needs of external client groups (Sponsor/vendor).
• Ensure quality and performance metrics are captured in an accurate and timely manner.
• Assist DSSM with accurate documentation, testing, validation and implementation of data management systems and process improvements/upgrades.
• Mentor, coach and train research staff on data management activities and processes, GCP, GCDMP, and applicable regulations.

Skills

Clinical Research

Data Management

Leadership

GCP

Education

Bachelor’s Degree

Tools

Electronic Source Systems

Job description

AbbVie in North Chicago, IL is seeking a Clinical Data Manager to support the conduct of clinical research trials in compliance with regulatory and company requirements. You will ensure data collection and transmission systems meet the needs of investigators, staff, and sponsors.

The role includes designing data collection systems reflecting protocols, maintaining data quality, and mentoring staff on GCP, GCDMP, and SOPs. A Bachelor’s degree and several years in clinical research are required.