Note: The job is a remote job and is open to candidates in USA. W. L. Gore & Associates is seeking a Clinical Systems Administrator to oversee and improve Clinical Affairs systems. The role leads system validation, configuration documentation, training, user access administration, troubleshooting, audit support, and compliance activities while partnering with study teams, stakeholders, vendors, and Clinical Quality Assurance.
Responsibilities
- 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
Skills
- • 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
Benefits
- This is a remote position, and you can work from home in most locations within the United States.
- We provide benefits that offer choice and flexibility and promote overall well-being.
- We provide a distinctive Associate Stock Ownership Plan in each country.
- Potential opportunities for “profit-sharing”.
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