Job Description
About the position We are looking for a Clinical Data Management Systems Administrator to. 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