Manager - Clinical Quality Compliance

Act as an expert advisor on ICH-GCP, ICON SOPs/WPs and all stages of study set-up, monitoring and study close-out for assessment of quality compliance processes for clinical trial management and site monitoring activities. Become involved, when required, in other areas of services and staff training and contribute to the review of ICON systems and quality procedures, as appropriate. Assist in development, tracking and trending departmental quality compliance in processes and metrics.

• Assess quality compliance through monitoring of quality metrics and/or key quality indicators
• Assess quality compliance processes for TMF to identify gaps and assist with corrective measures.
• Oversee assessment/trending of appropriate standard quality metrics related to clinical trial management and site monitoring and may personally conduct on-site co-monitoring visits.
• Develop, complete and perform QC of reports for management.
• Identify potential non-compliances, breaks of quality control steps taken by operations as measured through SOPs, WPs and industry standards.
• Identify and mitigate potential quality issues, GCP violations and non-compliance with internal or client SOPs/processes on project/portfolio/department level.
• Train and mentor new Clinical Quality Compliance (CQC) staff on processes and procedures.
• Provide CQC services to other operational departments and vendors, as required.
• Review of deliverables on project/portfolio/department level in conjunction with issues that are affecting the quality of the clinical deliverables to ensure quality standards are achieved.
• May travel up to 25% (both domestic & international)