Principal Clinical Data Manager

Job Summary

A company is looking for a Principal Clinical Data Manager.

Key Responsibilities

• Oversee vendor activities across global development programs and ensure alignment between CRO and client for data deliverables
• Lead collaboration with stakeholders to meet milestones and deliverables while maintaining quality standards
• Manage external Data Management budgets and timelines, ensuring compliance and readiness for inspections and audits

Required Qualifications

• MS or BS in a health-related, life sciences, or technology-related field
• Minimum of 10 years of experience in data management and drug development processes
• Proven project management skills with experience in large drug development programs
• Strong knowledge of FDA and ICH regulations related to data management
• Expertise in clinical trial documents and processes