eClinical Systems Analyst

The eClinical Systems Analyst role requires good knowledge of clinical trial processes and associated systems utilized, particularly focusing on Trial Master File (TMF) processes. In this position, you will support Study Owners in ensuring a complete, contemporaneous, and accurate TMF across our clients" clinical trials and programs. Your responsibilities will include assisting clients with the development, maintenance, and closeout of clinical trials using various eClinical systems such as eTMF, SSU, and CTMS. As an experienced individual in eClinical systems and the clinical trial process, your expertise in managing the TMF will be crucial. Your key responsibilities will involve collaborating with Study Owners on start-up, maintenance, and close-out activities related to the TMF. You will handle ongoing user management for eTMF and may be responsible for creating or maintaining events/placeholders in the system. Conducting TMF quality reviews, ensuring document accuracy and completeness, and communicating filing issues for further training evaluation will be part of your routine tasks. Additionally, you will assist in regulatory document review, compilation, and FDA submissions following GCP and ICH guidelines. As an eClinical Systems Analyst, you will identify and report trending TMF issues, provide support for metrics and report preparation, and contribute to inspection readiness by offering storyboard support. Data entry and analysis on CTMS, meeting minutes preparation, and other assigned tasks will also be expected. To excel in this role, you must possess superior communication skills, strong PowerPoint proficiency, and the ability to multitask effectively. Critical thinking, professionalism under pressure, good interpersonal skills, and attention to detail are essential. Building relationships with clients and colleagues, organizational skills, and knowledge of the Life Sciences industry are required. Proficiency in Microsoft Office tools and familiarity with ICH/GCP Guidelines are also important. Desired skills and experience include working with eTMF or other eClinical systems such as Veeva Vault or Wingspan IQVIA TMF, further enhancing your capabilities in this domain.,