Clinical Data Management System Administrator - Remote
About the position We are looking for a Clinical Data Management Systems Administrator to join our team. In this role, you will provide system administration and system oversight across all clinical systems, ensuring consistent processes and appropriate training documentation. This is a remote position, and you can work from home in most locations within the United States. Responsibilities • Perform all required day-to-day system administration activities for all clinical systems, including managing configurations and requirements, troubleshooting issues, providing support to system users, and interfacing with system vendors. • Lead and/or facilitate the Clinical Affairs validation of clinical systems, including cross-functional testing and validation efforts, managing system level testing and validation documentation, obtaining stakeholder input for system configurations, and managing system integrations. • Serve as expert resource, providing recommendations and best practices related to system configurations for study-specific uses, and promote the utilization of new and existing technologies. • Communicate system-related concerns, updates, and issues to functional leadership, internal stakeholders, and system users as needed. • Manage system level configuration documentation and manage a list of enhancement requests and defects known to impact active Clinical Systems. • Collaborate with internal stakeholders to identify training requirements for system access and manage system level training and documentation for all users. • Perform user role administration activities including granting, modifying, and revoking user access. • Partner with Clinical Quality Assurance (CQA) to promote quality and regulatory compliance with regard to clinical systems. • Keep up with industry best practices and emerging regulatory expectations in regard to computer systems validation. • Participate in process improvement initiatives. • Maintain knowledge of industry and regulatory trends as required to meet business needs. Requirements • Bachelor's degree or equivalent in background and experience. • Experience with Clinical Research Systems. • Experience working on cross-functional teams. • Experience with one or more of the following systems: Medidata EDC, Medrio EDC, Viedoc EDC, Veeva Vault eTMF, CTMS, and EDC. • Proficiency in desktop and/or web applications. • Organizational skills, flexibility, and ability to multi-task. • Strong verbal and written communication skills. • Knowledge of regulations and standards for use of clinical systems, namely 21 CFR part 11, ICH E6, and ISO-13841 and -14155. • Ability to quickly learn new tools and troubleshoot technical problems. • Ability to travel up to 5%. Nice-to-haves • Experience with clinical data management in medical device / pharmaceutical industry or equivalent. • Experience with computer system development lifecycle, including software validation testing and database testing. • Experience with systems validation processes used within a clinical research environment. Benefits • Comprehensive and competitive total rewards program. • Choice and flexibility in benefits promoting overall well-being. • Distinctive Associate Stock Ownership Plan. • Potential opportunities for profit-sharing. Apply tot his job