ESSENTIAL FUNCTIONS

• Guide a team of source systems specialists, grouped by either indication or region, by having a thorough understanding of region/indication-specific source needs, and manage respective team performance in all tasks assigned
• Assist in the training of junior team members in data systems utilization and source document creation, in accordance with the established departmental procedures and SOPs.
• Ensure continued quality control in the creation and maintenance of source forms to ensure data integrity
• Manage communication of priorities to ensure execution of goals and milestones through regular meetings, status updates, and other written communications
• Collaborate with other departments to make data-driven enhancements to source forms and CTMS working procedures
• Display a thorough understanding of the clinical research process, the clinical user experience, as well as a thorough understanding of the CTMS system used for data collection.
• Provide telephone, email and web support for the CTMS end user community, assisting them by logically diagnosing and resolving intermediate to advanced issues, as well as ensuring a timely escalation of unresolved issues to next level of support
• Maintain working knowledge of the CTMS system, including new releases and new products
• Communicate troubleshooting trends, regarding CTMS user processes and source documentation, with senior department members to facilitate data-driven process enhancements.
• Perform quality checks of source forms and CTMS troubleshooting procedures to ensure data integrity and process compliance.
• Review Sponsor protocols, eCRF guidelines, and other study-specific documentation to develop source forms to allow for efficient and accurate data collection to meet study-specific guidelines
• Program forms within the CTMS system as per study specifications, FDA guidelines, and company standards
• Maintain study builds from startup to closeout, updating forms as needed based on protocol amendments and updated company guidelines
• Communicate with internal staff to ensure the collection of study-specific documents needed for source form development (eg. Protocols, eCRF Guidelines, etc)
• Remote work compatible by displaying independent and proactive work habits
• Promptly attend scheduled meetings as required, available and eager to engage in department discussions.
• Display professional, efficient communication skills though timely follow up using the company's telephone, TEAMS, or email communication formats.
• Abide by GCP, SOPs, company guidelines, and local healthcare privacy regulations
• Other duties and responsibilities as assigned