Clinical Systems Administrator

We are looking for a Clinical Systems Administrator to join our team. In this role, you will drive the effective oversight, administration, and continuous improvement of Clinical Affairs systems. This role is responsible for leading clinical system validation and revalidation activities, maintaining system configuration and user access documentation, supporting training requirements, and partnering with internal stakeholders to ensure systems are used consistently and compliantly. The position also serves as a key resource for study teams by providing system expertise, troubleshooting support, and recommendations aligned with industry best practices, regulatory expectations, and business needs., * Lead and/or facilitate the Clinical Affairs validation of clinical systems. This can include 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.
• Manage system level configuration documentation (e.g., Rave core configuration, eTMF Non-administrative Changes).
• Collaborate with internal stakeholders to identify training requirements for system access. Manage system level training and documentation for all users across systems managed by Clinical Affairs (e.g., EDC, CTMS, eTMF, MITA).
• Perform user role administration activities including granting, modifying, and revoking user access. Coordinate with study teams to conduct regular system and study level user reviews (e.g., quarterly EDC reviews) and troubleshoot user access issues as needed.
• Support submission and audit activities related to system and user documentation.
• Manage a list of enhancement requests and defects known to impact active Clinical Systems and liaise with vendor technical contacts to address technical issues.
• Partner with Clinical Quality Assurance (CQA) to promote quality and regulatory compliance with regard to clinical systems.
• Communicate system-related concerns, updates, and issues to functional leadership, internal stakeholders, and system users as needed.
• Participate in process improvement initiatives., This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.

*Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.

What We Offer

Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits

• Bachelor’s degree or equivalent in background and experience
• Proficiency in desktop and/or web applications
• Ability to quickly learn new tools and trouble shoot technical problems
• Experience with Clinical Research Systems
• Organizational skills, flexibility, and ability to multi-task
• Strong verbal and written communication skills
• Experience working on cross-functional teams
• Familiar with 21 CFR part 11, * Experience with clinical data and/or study management in medical device / pharmaceutical industry or equivalent
• Experience with Clinical Systems Validation and FDA regulations
• Certified Vault Platform Administrator