What are the responsibilities and job description for the Clinical Research Compliance Operations Manager - 239874 position at Medix™?
Job Description
The Compliance Operations Manager is responsible for overseeing the daily operations of the compliance team across all teams and locations within the Clinical Trials Office (CTO). This individual will ensure seamless compliance processes and drive best practices for study types, audits, inspections, and regulatory adherence.
- Develop and implement consistent compliance metrics and reporting mechanisms for all study types.
- Track and assess Corrective and Preventative Actions (CAPAs) across audits, inspections, and Research Non-Compliance Issues (RNIs).
- Collaborate with the management team to identify trends, benchmark against external institutions, and ensure SOPs, policies, and workflows comply with all relevant local, state, and federal regulations.
- Provide strategic oversight and guidance for all compliance-related activities across CTO teams.
Candidate Requirements
- At least 5 years of clinical research experience, with most of it in oncology or a comparable field
- Prior project management or compliance experience
- Preferred prior experience managing staff
- Experience with audits is a huge plus
Additional Information
- Location: Downtown Chicago
- Schedule: Monday - Friday, normal business hours, onsite
- Team Size: Will oversee a team of no more than 10 people
- Reason for Opening: Growth and new leadership