Senior Manager, Clinical Data Management

Job Summary

Leading data management activities for clinical studies, the full-time Senior Manager, Clinical Data Management will oversee database build activities, monitor data collection by CROs, and ensure compliance with regulatory submissions while working remotely.

Key responsibilities

• Function as program level data management lead, managing direct reports and contributing as an individual contributor
• Oversee database build activities and monitor data collection, cleaning, and coding by CROs
• Provide strategic guidance and training to direct reports while ensuring adherence to departmental standards and regulatory requirements

Required qualifications

• BS/BA in a scientific discipline; MS or equivalent preferred
• At least 10 years of related experience in a pharmaceutical/biologics/biotechnology company
• Extensive experience managing global studies through Phase 3 in an outsourced CRO model
• Experience developing Data Management SOPs and standards
• Expert knowledge of eClinical processes and familiarity with Medidata Rave EDC system