Head eTMF Systems

Cookie Notice**WHAT -** **Summary & Purpose of the Position****WHAT -** **Main Responsibilities & Technical Competencies*** Lead the global eTMF strategy and roadmap, ensuring alignment with Ipsen’s R&D and CDO transformation initiatives and operating model.* Act as the eTMF business process owner, accountable for the quality, compliance and fitness-for-purpose of TMF content, processes and systems.* Ensure TMF operating standards, electronic clinical systems, data standards and related business processes support compliant, efficient end-to-end study management.* Serve as subject matter expert (SME) for eTMF management and inspection readiness, representing the function in audits, inspections and key governance forums.* Provide strategic oversight and governance of all eTMF-related activities and vendors, ensuring decisions are data-driven and risk-based.* Ensure fit-for-purpose training programmes, user guides, SOPs and e-learning materials are in place, regularly reviewed and updated...

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