Job Ref: 213894002

Date: 2021-06-03 15:44:08

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The client is looking for eTMF Specialist contractor with experience in Veeva Vault required to support this project.

Job Responsibilities:
-Perform an ongoing quality control of the eTMF, ensuring its inspection readiness i.e. completeness and compliance with the relevant requirements from study start-up until archiving.
-Escalate to the relevant functions any limiting factors and non-compliance related to the eTMF quality and provide comprehensive guidance on issue resolution.
-Monitor the eTMF quality issues and follow up with the relevant functions (sponsor / vendor) until their resolution.
-Provide support by eTMF related audit or inspections.
-Offer regular eTMF process guidance on the eTMF related requirements according to the applicable SOPs, WIs, guidelines, eTMF management plan. Provide practical support to eTMF users on the use of the system.
-Contribute to the revisions of the eTMF process and system enhancements.
-Perform review of the eTMF management plans and provide relevant input.
-Arrange secure shipments of wet-ink documents.

The duration of the project is for 6 months

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