Quality Review Specialist

The Quality Review Specialist is responsible for performing periodic TMF Quality Reviews for assigned projects in a timely manner and with high quality, ensuring TMFs are maintained in an audit-ready manner.

Requirements

• Performs periodic TMF Quality Reviews for assigned projects in a timely manner and with high quality
• Ensures that TMF documentation related to periodic TMF Quality Reviews is generated and filed in the TMF
• Informs the TMF Lead if the TMF is not updated with the information related to countries, sites, contacts and applicable TMF document requirements
• Supported by Manager, monitors and escalates to the TMF Lead document processing issues and inconsistences, missing/incorrect documents filed by the Functional Leads, non-response of the Functional Leads related to periodic Quality Review requests or questions
• During periodic Quality Reviews, supports updates to expected documents and opening of placeholders in TMF, where needed
• Where possible, identifies potential training needs for all team members working in the TMF to encourage high quality and consistent maintenance of the TMF
• Supported by Manager, identifies and escalates to TMF leadership studies at serious risk based on poor quality