Documentation Manager

Job Summary

Managing the full lifecycle of study operations documentation, the remote Documentation Manager will ensure compliance, accuracy, and version control of testing and validation records while driving process improvements and regulatory adherence.

Key responsibilities

• Collaborate with various teams to draft, format, and finalize study-related documentation
• Ensure all documentation meets regulatory requirements and prepare materials for audits and inspections
• Establish and manage documentation processes and standards, training team members on best practices

Required qualifications

• Bachelor's degree in business, information systems, or a related field
• 5+ years of experience in clinical research, quality assurance, or system validation
• A minimum of 2 years in a documentation management role
• Strong knowledge of GxP, FDA regulations, and ICH guidelines
• Proficiency with document management systems such as VeevaVault or MasterControl