Clinical Systems Specialist
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Job Description
Clinical Systems Specialist administering Veeva eTMF and CTMS for Waters, a life sciences analytical technology company. Supporting compliant clinical operations, reporting, training, and system optimization.
Responsibilities:
- Administer and support Veeva eTMF and Veeva CTMS, including user provisioning, role configuration, access management, and access reviews
- Provide end-user support, troubleshoot system issues, and coordinate resolutions
- Monitor system performance, usability, and data quality
- Support system releases, upgrades, enhancements, configuration changes, testing, validation documentation, and defect tracking
- Maintain configuration records, work instructions, training materials, and other system documentation
- Configure system objects, workflows, reports, dashboards, metadata, and user permissions
- Execute data loads, bulk updates, and data remediation activities
- Support system integrations and data exchange processes
- Support TMF health, completeness, quality, inspection readiness, reconciliation, audits, and regulatory inspections
- Monitor CTMS data quality and support study, site, milestone, and operational tracking
- Generate reports, dashboards, metrics, and KPIs for study teams and management
- Partner with Clinical Operations and study teams to ensure compliant platform use
- Develop and deliver user training, job aids, and quick reference guides
- Promote best practices and drive system adoption
- Identify workflow automation, process simplification, and operational efficiency opportunities
- Participate in cross-functional clinical systems and process improvement initiatives
- Evaluate new technologies and stay current on industry trends, regulatory expectations, and best practices
- Ensure system activities comply with company procedures, regulatory requirements, and quality standards
Requirements:
- Bachelor's degree in Life Sciences, Clinical Research, Information Systems, Healthcare Administration, or a related field
- Minimum of 2 years of experience in Clinical Operations, Clinical Systems, Medical Affairs Operations, TMF Management, or related functions
- Minimum of 2 years of experience supporting, administering, or configuring eTMF and/or CTMS platforms
- Experience working in a regulated GxP environment
- Experience supporting, configuring, or administering clinical systems, preferably eTMF and/or CTMS platforms
- Experience with user management, role-based security, reporting, dashboards, workflows, and system configuration
- Experience performing data maintenance activities, including bulk updates, data imports, and data quality reviews
- Ability to analyze business processes and identify opportunities for system optimization and automation
- Experience developing user documentation, training materials, and standard operating procedures
- Proficiency with Microsoft Office applications, including Excel, PowerPoint, Teams, and SharePoint
- Working knowledge of ICH Good Clinical Practice (ICH-GCP), 21 CFR Part 11, HIPAA, GDPR, DIA TMF Reference Model, GAMP 5, Software Development Lifecycle (SDLC), and clinical trial documentation and inspection-readiness principles
- Strong analytical and problem-solving skills
- Excellent organizational skills and attention to detail
- Strong written and verbal communication skills
- Ability to manage multiple priorities and deadlines effectively
- Ability to work independently while collaborating effectively across functions
Benefits:
- Comprehensive Total Rewards program
- Reward and recognition opportunities
- Competitive compensation and benefits programs
- Learning, growth, and development opportunities
- Workplace accommodations considered pursuant to applicable law
- Flexible work-life balance considerations for remote or field-based positions
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