Senior Clinical Data Manager

Job Summary

Leading data management activities for early phase clinical pharmacology studies, the full-time Senior Clinical Data Manager will oversee complex studies, collaborate with cross-functional teams, and ensure timely, accurate data management to support safety reviews and study conduct in a remote environment.

Key responsibilities

• Manage and monitor data management activities and vendor relationships for assigned studies
• Lead the design and testing of Electronic Data Capture (EDC) systems and ensure compliance with data capture requirements
• Provide mentorship and training to junior Data Management staff while participating in process improvement initiatives

Required qualifications

• At least five years of experience in Data Management within the pharmaceutical/biotechnology industry, including two years leading Phase I studies
• Comprehensive understanding of regulatory guidelines and industry standards related to Data Management
• Strong project management skills with the ability to prioritize multiple tasks effectively
• Experience in supporting Phase I Healthy Volunteer clinical pharmacology studies
• BA/BS degree, preferably in a scientific or healthcare field