Director, Clinical Operations Excellence
April 18
Description
• Reporting to the Vice President, Clinical Operations, the Director, Clinical Operations Excellence successful candidate will be skilled at both understanding and applying global clinical compliance regulations and processes relating to clinical trials as they advance through clinical development. • The candidate will support inspection readiness efforts to manage and support a culture of proactive inspection readiness, data quality, integrity, and regulatory compliance. • Assist the Clinical team with the development and revision of Standard Operating Procedures, Work Instructions and Templates as well as assisting with the effective development and resolution of deviations, CAPAs, audit, and regulatory inspection findings.
Requirements
• Minimum of 10+ years relevant experience in clinical research with direct clinical compliance oversight. • Bachelor’s level degree in life sciences or related field or related experience. • Experience in Inspection Readiness preparation required. • Documented training, advanced working knowledge, and application of current Regulations, and ICH GCP guidelines. • Identify areas for process improvement and lead discussions to implement change. • Build strong relationships with peers and partners both within and across function teams.
Benefits
• 11 paid holidays • Generous Accrued Time Off increasing with years of service • Generous paid sick time • Annual day of service
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