eClinical Systems Analyst

As an eClinical Systems Analyst, you will have a solid understanding of clinical trial processes and the systems involved. Your main focus will be on ensuring the completeness, contemporaneousness, and accuracy of the Trial Master File (TMF) for our clients' clinical trials and programs. You will work closely with Study Owners to provide support and assistance in various aspects of clinical trial management using eClinical systems such as eTMF, Study Start up (SSU), and Clinical Trial Management System (CTMS). Key Responsibilities: - Collaborate with Study Owners on start-up, maintenance, and closeout activities related to the TMF - Manage ongoing user activities within the eTMF system - Create and maintain events/placeholders in the eTMF as needed - Conduct quality reviews of TMF documents to ensure accuracy and completeness - Identify and communicate systematic filing issues to the manager for further evaluation - Perform periodic quality reviews of regulatory documents for each active study site - Assist in the review and compilation of regulatory documents for FDA submissions following GCP and ICH guidelines - Report TMF trending issues to relevant stakeholders and propose resolutions - Prepare metrics and reports on TMF Key Performance Indicators (KPIs) - Provide support for inspection readiness through storyboard maintenance - Carry out data entry and analysis in the Clinical Trial Management System (CTMS) for both CTMS and enterprise clients - Assist with meeting minutes and agendas - Handle any other tasks assigned by the manager/supervisor Qualifications Required: - Experience with eClinical systems, particularly in managing the clinical trial process and TMF - Strong knowledge of clinical trial processes and associated systems - Familiarity with regulatory requirements and guidelines such as GCP and ICH - Excellent communication skills to interact with various stakeholders effectively Note: The above description focuses on the responsibilities and qualifications required for the position of eClinical Systems Analyst. As an eClinical Systems Analyst, you will have a solid understanding of clinical trial processes and the systems involved. Your main focus will be on ensuring the completeness, contemporaneousness, and accuracy of the Trial Master File (TMF) for our clients' clinical trials and programs. You will work closely with Study Owners to provide support and assistance in various aspects of clinical trial management using eClinical systems such as eTMF, Study Start up (SSU), and Clinical Trial Management System (CTMS). Key Responsibilities: - Collaborate with Study Owners on start-up, maintenance, and closeout activities related to the TMF - Manage ongoing user activities within the eTMF system - Create and maintain events/placeholders in the eTMF as needed - Conduct quality reviews of TMF documents to ensure accuracy and completeness - Identify and communicate systematic filing issues to the manager for further evaluation - Perform periodic quality reviews of regulatory documents for each active study site - Assist in the review and compilation of regulatory documents for FDA submissions following GCP and ICH guidelines - Report TMF trending issues to relevant stakeholders and propose resolutions - Prepare metrics and reports on TMF Key Performance Indicators (KPIs) - Provide support for inspection readiness through storyboard maintenance - Carry out data entry and analysis in the Clinical Trial Management System (CTMS) for both CTMS and enterprise clients - Assist with meeting minutes and agendas - Handle any other tasks assigned by the manager/supervisor Qualifications Required: - Experience with eClinical systems, particularly in managing the clinical trial process and TMF - Strong knowledge of clinical trial processes and associated systems - Familiarity with regulatory requirements and guidelines such as GCP and ICH - Excellent communication skills to interact with various stakeholders effectively Note: The above description focuses on the responsibilities and qualifications required for the position of eClinical Systems Analyst.