Clinical Systems Specialist

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Manage and provide support for Veeva eTMF and Veeva CTMS, which includes user provisioning, role configuration, access management, and access reviews.

• Offer end-user assistance, resolve system issues, and coordinate solutions.

• Oversee system performance, usability, and data integrity.

• Assist with system releases, upgrades, enhancements, configuration changes, testing, validation documentation, and defect tracking.

• Keep configuration records, work instructions, training materials, and other system documentation updated.

• Configure system objects, workflows, reports, dashboards, metadata, and user permissions.

• Execute data loads, bulk updates, and data remediation tasks.

• Aid in system integrations and data exchange procedures.

• Ensure TMF health, completeness, quality, inspection readiness, reconciliation, audits, and compliance with regulatory inspections.

• Track CTMS data quality and support study, site, milestone, and operational monitoring.

• Create reports, dashboards, metrics, and KPIs for study teams and management.

• Collaborate with Clinical Operations and study teams to ensure proper platform usage.

• Design and deliver user training, job aids, and quick reference guides.

• Encourage best practices and drive system adoption.

• Identify opportunities for workflow automation, process simplification, and operational efficiency.

• Engage in cross-functional clinical systems and process improvement projects.

• Assess new technologies and stay informed about industry trends, regulatory expectations, and best practices.

• Ensure that system activities adhere to company protocols, regulatory requirements, and quality standards.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Clinical Research, Information Systems, Healthcare Administration, or a related discipline.

• At least 2 years of experience in Clinical Operations, Clinical Systems, Medical Affairs Operations, TMF Management, or similar roles.

• A minimum of 2 years of experience in supporting, administering, or configuring eTMF and/or CTMS platforms.

• Experience in a regulated GxP environment.

• Familiarity with supporting, configuring, or administering clinical systems, ideally eTMF and/or CTMS platforms.

• Experience with user management, role-based security, reporting, dashboards, workflows, and system configuration.

• Proven experience in data maintenance activities, including bulk updates, data imports, and data quality assessments.

• Ability to analyze business processes and identify potential areas for system optimization and automation.

• Experience in creating user documentation, training materials, and standard operating procedures.

• Proficient in Microsoft Office applications, including Excel, PowerPoint, Teams, and SharePoint.

• Familiarity with ICH Good Clinical Practice (ICH-GCP), 21 CFR Part 11, HIPAA, GDPR, DIA TMF Reference Model, GAMP 5, Software Development Lifecycle (SDLC), and principles of clinical trial documentation and inspection readiness.

• Strong analytical and problem-solving capabilities.

• Excellent organizational skills and meticulous attention to detail.

• Strong written and verbal communication skills.

• Ability to effectively manage multiple priorities and deadlines.

• Capability to work independently while also collaborating effectively across various functions.

🏝️ Benefits

• Comprehensive Total Rewards program.

• Opportunities for rewards and recognition.

• Competitive compensation and benefits packages.

• Opportunities for learning, growth, and development.

• Consideration for workplace accommodations as per applicable laws.

• Flexible work-life balance options for remote or field-based roles.