Senior Clinical Research Operations Manager

Biological Sciences Division at the University of Chicago; Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

The Biological Sciences Division at the University of Chicago seeks a Clinical Research Manager to lead the Research Incubation Unit, directing a team responsible for clinical trial data collection, analysis, and reporting. You will support startup and ongoing studies, manage milestones, and ensure compliance with regulatory standards across the enterprise.

Reporting to the Director of Clinical Research Operations, you will recruit, onboard, and train staff, oversee performance metrics, and

Qualifications

• Master's degree strongly preferred.
• 7+ years of related work experience.
• Experience with FDA-regulated clinical trials and site management.
• Regulatory support for FDA and IRB filings.
• Protocol development support experience.

Responsibilities

• Oversee clinical research portfolio lifecycle from feasibility to closeout.
• Coordinate department clinical research staff and meetings.
• Ensure regulatory compliance and IRB filings across projects.
• Establish documentation standards and SOPs for reviews and feasibility.
• Mentor and train staff in GCP and regulatory requirements.
• Manage protocol reviews and coordination of review processes.
• Lead initiatives to improve data quality and study performance.

Skills

Team leadership

Regulatory compliance

Clinical research

FDA/IRB filings

Education

Master's Degree

ACRP/SOCRA certification

Job description

The Biological Sciences Division at the University of Chicago seeks a Clinical Research Manager to lead the Research Incubation Unit, directing a team responsible for clinical trial data collection, analysis, and reporting. You will support startup and ongoing studies, manage milestones, and ensure compliance with regulatory standards across the enterprise.

Reporting to the Director of Clinical Research Operations, you will recruit, onboard, and train staff, oversee performance metrics, and