eClinical Systems Analyst

As an eClinical Systems Analyst, your role involves having a good understanding of clinical trial processes and related systems, particularly focusing on the Trial Master File (TMF) processes. You will work closely with Study Owners to ensure that the TMF is complete, contemporaneous, and accurate across all clinical trials and programs conducted by our clients. Your responsibilities will include assisting clients in the development, maintenance, and closeout of clinical trials using various eClinical systems such as eTMF, Study Start up (SSU), and Clinical Trial Management System (CTMS). Your key responsibilities in this role will include: - Collaborating with Study Owners on start-up, maintenance, and closeout activities related to the TMF - Managing ongoing user activities in the eTMF system - Creating and maintaining events/placeholders in the eTMF as required - Conducting quality reviews of the TMF to ensure document content and metadata accuracy, as well as completeness - Reporting systematic filing issues to the manager for further evaluation and training - Performing periodic quality reviews of regulatory documents at each active study site, including IRB Renewal, IRB Protocol Approval, Informed Consent Review, and more - Drafting, reviewing, and approving TMF Quality plans and reports, and reconciling findings - Assisting in regulatory document review and compilation for FDA submissions following GCP and ICH guidelines - Identifying and reporting TMF trending issues and concerns to relevant stakeholders for resolution - Supporting metrics and report preparation for TMF Key Performance Indicators (KPIs) related to completeness, quality, and timeliness - Providing storyboard support and maintenance to ensure inspection readiness - Conducting data entry and analysis in the Clinical Trial Management System (CTMS) for both CTMS and enterprise clients - Managing meeting minutes and agendas effectively - Completing any other tasks deemed appropriate for the role as assigned by the manager/supervisor Your experience with eClinical systems, especially in the context of clinical trial processes and TMF management, will be valuable in this position. Your attention to detail, ability to communicate effectively, and proactive approach to problem-solving will contribute to the successful execution of clinical trials for our clients.,