Provide just-in-time guidance to study teams on key operating model processes and required documentation, prioritizing real-time inspection readiness. Manage and guide teams on inspection readiness planning, including developing and maintaining inspection readiness plans and tools in collaboration with cQA and GCP Excellence in Clinical Trials leadership.
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Play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions. You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation.