Codera

Manager

• Review study documents received from study teams for completeness and accuracy and upload them to the Trial Master File (TMF)
• Perform quality control and quality reviews of TMF documents according to SOPs, work instructions, and guidance documents
• Ensure documents failing TMF quality control or review are remediated and provide best-practice recommendations
• Support TMF and CTMS inspection readiness for clinical studies
• Provide feedback, support, and training to study teams on quality documentation management practices
• Conduct TMF educational workshops and training as needed
• Address questions about document filing and TMF system use
• Maintain Essential Document Lists (EDLs)
• Perform secondary review of site Essential Document Packages for site activation and Investigational Product release
• Maintain the Clinical Trial Management System (CTMS), including study-, country-, and site-level updates, and review entries for accuracy
• Contribute to TMF QC tools and materials, including the QC Tool, QC Manual, Doc Owner Manual, and TMF newsletters
• Maintain current knowledge of the TMF Reference Model, industry best practices, and applicable regulatory considerations
• Assist with inspection and audit activities, including preparation and corrective action plans
• Execute other duties as assigned

Manager/Senior Manager, Records Management