Manager/Senior Manager, Records Management

The Manager, Records Management will provide support for TMF activities by ensuring documents uploaded to the TMF adhere to Standard Operating Procedures, ICH GCP guidelines and other regulatory requirements. The Manager will act as a TMF Subject Matter Expert (SME) and work with the study teams to ensure the TMFs and CTMS for clinical studies are inspection ready at all times. Essential Duties and Responsibilities Review study documents received from the study teams for completeness and accuracy and upload to the Trial Master File (TMF) Perform quality control of documents submitted to the TMF per SOPs, Work Instructions and Guidance Documents. Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed. Perform TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times. Provide feedback, support and training to study teams to build knowledge and awareness of good, quality documentation management practices for clinical trials. Conduct TMF educational workshops/training, as needed. Address TMF questions pertaining to how documents are filed, and user questions related to the TMF system. Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis. Perform the secondary review of site Essential Document Packages per applicable SOPs to ensure sites meet the requirements for site activation and In