Clinical Systems Administrator

Responsibilities

The Clinical System Administrator (CSA) is responsible for the management, oversight, and maintenance of the eTMF (Electronic Trial Master File) and CTMS (Clinical Trial Management System) system. The CSA Administrator ensures that the following for each platform:

• eTMF: The system is fully operational, compliant with regulatory standards, and supports the proper documentation of clinical trials and observational studies. This involves providing technical support and training and ensuring study documentation quality, completeness, and integrity within the eTMF.
• CTMS: The effective administration, configuration, and support of the CTMS platform, ensuring it meets the needs of the study operations. This role will support clinical teams by ensuring accurate study data tracking, reporting, and seamless integration of CTMS with other systems. The CTMS Administrator also provides administration, support, system training, integration, and compliance with industry regulations.
  
  

Specific Job Duties

• System Configuration & Management:
• CTMS:
• Define and manage standard study build configuration to support study operations, including but not limited to study definition, site configuration, subject tracking, enrollment projection and tracking, issue and action tracking, protocol deviation, and site payment processing.
• Assist the study team with custom study-specific configurations and timely setup of CTMS to align with protocol, study parameters, and timelines.
• Act as CTMS Subject Matter Expert (SME) to assist with custom workflows and project configurations required to support a study.
• eTMF:
• Maintain default configuration for eTMF projects to support clinical study and PV safety organization. This includes the accuracy and completeness of project standard configuration documentation and configuration scripts.
• Accurate and timely setup of eTMF projects to align with the clinical study and PV project timelines.
• Act as eTMF Subject Matter Expert (SME) to assist with custom workflows and project configurations required to support a study or PV program.
• Support the transfer and archiving of study documents to meet regulatory retention requirements.
• All systems:
• Interface with project teams to assist with custom configuration and documentation of any custom security configuration for a program.
• Ensure complete security compliance with all programs through oversight of all security reviews & audits defined in UBC SOPs.
• Manage all system upgrades, patches, and new feature release processes, coordinating with UBC program teams, impacted technology teams, UBC Quality Assurance (if required), and CTMS/eTMF vendors. Responsibilities can include but are not limited to project communications, system validation, UAT testing, and updating all necessary configuration and product documentation.
• System Security:
• Define and manage a comprehensive security document that documents application and project-level access rights and security roles.
• Define, document, and maintain the mapping of application security roles to proper job functions and project roles.
• Define and train project teams on processes related to assigning project team members to proper application security roles.
• Design, oversee, and monitor security review and user access verification processes to ensure the security and integrity of eTMF, CTMS, and SPO systems.
• User Support & Training:
• Provide first-line technical support for CTMS and eTMF users through troubleshooting and researching system-related issues.
• Act as single point-of-contact between UBC and vendor related to support escalations, enhancement requestions, and monitoring/communication of vendor system outages.
• Interface with UBC LOB leadership to develop and maintain system training plans by aligning vendor training materials (documents, video, online live, etc.) with defined organizational roles.
• Upon the release of a system upgrade, ensure all training material is up to date and aligned with proper roles and system functions.
• Confirm all roles and application functions are assigned all proper training materials
• On a bi-annual basis, verify all user training and communicate to management all employees who are out of compliance with the required training courses.
• Compliance & Documentation:
• Ensure all administered clinical systems complies with regulatory standards, including GCP, ICH, FDA 21 CFR Part 11, EU Annex 11, and other relevant guidelines.
• Maintain thorough documentation of system configurations, validations, and procedures.
• Collaborate with QA and clinical teams to support internal and external audits and regulatory inspections, ensuring that all supported clinical systems are audit-ready at all times.
• Author and/or contribute to CTMS and eTMF SOPs and WPs
• Data Integrity & Reporting:
• Oversee the integration of all supported clinical systems with other systems and vendors (e.g., EDC, eTMF, CTMS, financial systems), ensuring data synchronization and smooth workflows.
• Troubleshoot and resolve integration issues, collaborating with IT teams and vendors as necessary.
• System Improvement and Optimization:
• Identify and recommend opportunities to improve and streamline all supported clinical systems processes to enhance efficiency and compliance.
• Collaborate with eTMF and CTMS vendors to request new system features, resolve bugs, and ensure continuous improvement.
• Stay updated on the latest eTMF and CTMS industry trends, technologies, and best practices.

Supervisory Responsibility:

N/A

Desired Skills And Qualifications

• Education:
• Bachelor's degree in Life Sciences, Information Technology, or a related field. Equivalent work experience may be considered.
• Experience:
• Minimum of 2-4 years of experience administering a CTMS and/or eTMF in a CRO, pharmaceutical, or biotechnology setting.
• Experience with leading CTMS and eTMF platforms such as Medidata, Oracle Siebel CTMS, Veeva, or similar.
• Experience working within clinical trial operations, with a strong understanding of study management, regulatory requirements, and data tracking.
• Technical Skills:
• Proficiency in CTMS and eTMF administration, configuration, management, and reporting.
• Familiarity with data integration processes between CTMS/eTMF and other systems (e.g., EDC, eTMF, finance systems).
• Experience in troubleshooting technical issues and providing user support.
• Basic knowledge of SQL
• Knowledge with SSRS, Tableau, or PowerBI reporting tools is a plus.
• Soft Skills:
• Strong organizational and multitasking skills, with the ability to manage multiple projects simultaneously.
• Excellent communication and interpersonal skills, with the ability to collaborate with clinical teams, IT, and external vendors.
• Problem-solving mindset with a focus on process improvement and operational efficiency.

Preferred Qualifications:

• Previous experience working in a CRO environment.
• Experience in system validation and compliance audits.
• Veeva Certified Administrator for any module
  
  

Knowledge of additional clinical systems like EDC, IVRS, or Safety databases.