The Clinical Systems Administrator is responsible for the overall management, configuration, and optimization of Canopy, Alimentiv's project and resource management solution built in Smartsheet. This role ensures the stability, scalability, and security of clinical systems, working to guarantee they meet the needs of clinical operations and regulatory compliance. The administrator oversees system architecture, performs routine maintenance, and implements system upgrades to enhance performance and functionality. The Clinical Systems Administrator also ensures the integrity and interoperability of clinical systems across platforms, collaborating with IT teams, vendors, and cross-functional stakeholders to address technical issues and integrate new technologies. They lead system validation activities and are responsible for ensuring all systems comply with regulatory requirements such as FDA 21 CFR Part 11. Additionally, the administrator provides expert-level user support, training, and troubleshooting. Ultimately, the Clinical Systems Administrator ensures that clinical systems remain secure, efficient, and reliable to support the successful execution of global clinical trials.
System Strategy & Governance (10-20%)
- Lead implementation of the system roadmap to align with the organization's strategic goals.
- Work with stakeholders to gather requirements and translate them into system enhancements
- Support vendor selection and management for technology solutions.
- Leads or supports risk management activities
- Leads or supports data governance initiatives to ensure data integrity of clinical system(s)
System Development & Implementation (20-30%)
- Leads system lifecycle activities including system implementation, system configuration and validation, system updates, and change management activities
- Collaborate with IT and clinical teams to improve system efficiencies and automation.
- Assist in evaluating and integrating third-party applications and vendors.
System Maintenance, Security & Compliance (30-40%)
- Ensure the availability and reliability of systems, working with the technology vendor and IT as appropriate.
- Monitor system performance and security, applying necessary patches and updates as relevant.
- Manage user accounts, permissions, and access controls in compliance with regulatory standards such as GxP, 21 CFR Part 11, and GDPR.
- Support audit activities (sponsor audits, vendor audits and regulatory audits) to demonstrate compliance
- Ensure system’s compliance with IT policies, SOPs, and regulatory requirements.
User Support & Training (10-20%)
- Provide technical support to end-users and troubleshoot system-related issues.
- Conduct training sessions for staff on system usage.
- Document processes, configurations, and troubleshooting guides.
QUALIFICATIONS
- Proficiency in Smartsheet required
- 7 – 9 years of related experience
- Fluent in the reading, writing and speaking of English
- Bachelor's degree in computer science or a related field is preferred.
- Strong ability to align technology strategies with business goals and operational requirements.
- Proficiency in managing clinical systems (E.g., CTMS, eTMF) and tools.
- Skills in integrating various software systems, diagnosing system issues, and ensuring smooth system performance across diverse platforms.
- Knowledge of IT security protocols and regulatory compliance requirements (e.g., FDA 21 CFR Part 11,) including implementing secure access controls and ensuring data integrity and audit trails in clinical systems
- Project Management and Organization: Strong organizational and time-management abilities to handle multiple projects simultaneously, ensuring timely implementation of system changes or upgrades.