Facilitates clinical document management activities. This includes, but may not be limited to:Ensures the proper application of regulatory requirements pertaining to the management of clinical documents.Ensures electronic trial master files (eTMF) are compliant with relevant regulatory requirements by performing periodic and ad hoc reviews/audits of TMF. This includes the reconciliation of the TMF at study close-out.Responds to TMF-related inquiries and resolves issues within stipulated timelines.Performs quality checks of TMF-related documents, including clinical study site documents, email correspondence, training materials, and other related study documents.Applies ICH guidelines to generate filing indices.Maintains current lists of correspondence. Contributes to health authority inspection readiness by providing requested documents, from the TMF.Liaises with Contract Research Organization (CRO) to ensure stud...
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