You have a strong track record in sponsor oversight for Phase II/III trials and hands-on TMF (eTMF) management, with measurable improvements in quality, completeness, and timeliness. * You will lead and coordinate clinical operational excellence initiatives including inspection readiness initiatives across Clinical Development EU, ensuring compliance with GCP, SOPs, and regulatory requirements while driving efficiency and high-quality standards. * Together with your team you will oversee TMF services, trial oversight- and training requirements for clinical studies, including Key Peformance Indicator management, TMF vendor oversight, and proactive risk mitigation. * You will support the ClinDev EU team with audits and regulatory inspections by preparing documentation, tracking CAPAs, and reviewing trial-related manuals and plans to communicate quality requirements.
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