Praxis

Operations

• Ensure clinical trial documentation is accurate, complete, and inspection-ready
• Serve as TMF subject matter expert and trusted partner to study teams
• Oversee eTMF set-up, maintenance, and regular quality reviews
• Monitor TMF health, milestones, and deliver metrics and insights to teams
• Guide and support trial teams to stay compliant with document lists and timelines
• Identify and resolve TMF issues and escalate when needed
• Contribute to SOPs, processes, and industry best practices
• Ensure access and compliance with global TMF standards and regulations

TMF Operations Lead

• Collaborate with and support stakeholders within Analytical Development, Regulatory CMC, and Quality Assurance to ensure alignment on stability strategies and compliance with ICH guidelines.
• Ensure that analytical documentation (protocols, reports, change controls, etc.) are added contemporaneously to Praxis’ document management system.
• Contribute to regulatory filings (e.g., IND, IMPD, NDA) by preparing stability summaries and providing supporting information.
• Collaborate with other functions of Praxis CMC to execute the technical and business practices of the team.
• Lead the establishment, execution, and management of stability studies internally and at CDMO partners for drug substance and drug products across all development phases.
• Monitor CDMO performance with respect to agreed timelines for providing stability protocols and reports and establish metrics as needed.
• Review raw data, calculations, stability protocols, and stability summary reports in direct support of the Analytical Development Project Leads.
• Perform trend analysis of stability data to be used in shelf-life assessment.
• Ensure timely data review to support OOT/OOS investigations and implementation of corrective actions related to stability studies.
• Monitor execution of reference standard lifecycle management, including qualification, requalification, inventory, and expiry tracking in coordination with external testing sites.

TMF Operations Lead

Manager/Senior Manager, Analytical Operations