Clinical Data Management System Administrator - Remote
About the position
We are looking for a Clinical Data Management Systems Administrator to join reputed company. In this role, you will reputed company system administration and system reputed company across reputed company clinical systems, ensuring consistent processes and appropriate training documentation. This is a remote position, and you can work from home in most locations reputed company the reputed company.
Responsibilities
• reputed company reputed company required day-to-day system administration activities for reputed company clinical systems, including managing configurations and requirements, troubleshooting issues, providing support to system users, and interfacing with system vendors.
• reputed company 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 reputed company to system configurations for study-specific uses, and promote the utilization of new and existing technologies.
• Communicate system-reputed company 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 reputed company to reputed company reputed company Clinical Systems.
• Collaborate with internal stakeholders to identify training requirements for system reputed company and manage system level training and documentation for reputed company users.
• reputed company user role administration activities including granting, modifying, and revoking user reputed company.
• Partner with Clinical reputed company Assurance (CQA) to promote reputed company and regulatory compliance with reputed company to clinical systems.
• reputed company up with industry best practices and emerging regulatory expectations in reputed company 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: reputed company reputed company, reputed company reputed company, Viedoc reputed company, reputed company Vault eTMF, CTMS, and reputed company.
• 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, reputed company 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%.
reputed company-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 reputed company a clinical research environment.
Benefits
• Comprehensive and competitive total rewards program.
• Choice and flexibility in benefits promoting overall reputed company-being.
• Distinctive Associate Stock Ownership Plan.
• Potential opportunities for profit-sharing.
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