Associate Director of Data Management

Job Summary

A company is looking for an Associate Director, Data Management Processes, Training, and Inspection Readiness.

Key Responsibilities

• Lead the development and implementation of Data Management strategies and processes
• Coordinate and manage updates to cross-functional SOPs and ensure compliance
• Prepare internal teams for audits and participate in external inspections

Required Qualifications

• Bachelor's Degree in life sciences or related field required; Master's Degree preferred
• 7 or more years of training and compliance experience with knowledge of FDA and EU regulatory requirements
• 7 or more years of clinical data management experience in a medical device or pharmaceutical environment
• Strong knowledge of GCP, GDP, and 21 CFR preferred
• Experience with clinical trial data systems and/or EDC lab management tools preferred