Senior Clinical Data Manager

Job Summary

A company is looking for a Senior Clinical Data Manager who will lead data management study activities and ensure compliance with regulatory standards.

Key Responsibilities

• Independently lead data management study activities and oversee CRO deliverables
• Ensure compliance and readiness for audits and regulatory submissions
• Collaborate with stakeholders to manage external data management budgets and timelines

Required Qualifications

• Proven experience as a Lead Clinical Data Manager with substantial RAVE experience
• Bachelor's Degree in a science, health-related, or information technology field
• Minimum 6 years of experience in Clinical Data Management, including at least 2 years as a Lead
• Strong knowledge of FDA and ICH regulations and clinical trial processes
• Understanding of data management best practices and technologies in clinical trials