Study Configuration/clinical Systems Specialist, Tech Delivery, Cronos

Clinical Systems Support Specialist

Provide a wide range of support functions for clinical systems applications and act as the first line of support for system configuration issues among clinical and systems staff. Work directly with systems teams and end users to ensure clinical systems are properly configured, operational, maintained, and that users are adequately trained.

Essential Functions:

• Act as a system administrator to configure clinical applications in alignment with study protocols, business workflows, and delivery milestones
• Ensure system readiness and support technical staff with internal and external system interfaces
• Adhere to standard procedures and work instructions related to system setup
• Conduct and document system validation activities in accordance with SDLC policies, including system interfaces
• Provide technical support to Technical Development and Delivery teams on application interface design and application-dependent deliverables (e.g., reports, data transfers)
• Maintain and update controlled documentation and project-specific guidelines (SOPs, Work Instructions, manuals)
• Ensure consistent use of designated clinical systems and adherence to standard and project-specific system use cases
• Perform quality control (QC) checks within projects and provide reports to PMs/CTLs on system navigability, performance, and data integrity
• Deliver training on designated clinical systems to local, regional, and project teams
• Identify, document, and escalate system quality and performance issues
• Recommend and support solutions for study-specific system setup and configuration
• Perform ad-hoc analyses and generate metric reports to support business and system performance requirements
• Participate in maintenance, QC, and end-use of roadmap-support applications tracking system requirements and configuration workstreams
• Provide training, coaching, and ongoing support to Clinical Systems Specialists and system champions
• Serve as a system feature and functionality expert supporting IT design, planning, and implementation of system changes
• Conduct UAT testing, develop training materials, and provide end-user support
• Participate in requirements gathering and approval of reports and data outputs based on system configuration and protocol knowledge
• Act as a Subject Matter Expert (SME) for new joiners and team members
• Design and deliver training content related to system configuration processes

Qualifications:

• Bachelor's degree in Biological Sciences, Health, Healthcare Informatics, or a related field
• Typically 2–3 years of relevant experience
• Intermediate knowledge of clinical trial application use cases and data flow, gained through education and experience
• Demonstrated knowledge of applicable SOPs, Work Instructions, and regulatory guidelines
• Advanced working knowledge of designated clinical systems, processes, and system interdependencies
• Ability to work cross-functionally with an understanding of IQVIA project team structures
• Strong computer literacy, including proficiency with Microsoft 365 (Outlook, Excel, Word, PowerPoint)
• Effective problem-solving and analytical skills
• Strong communication and interpersonal skills
• Excellent organizational skills with strong attention to detail
• Ability to run and QC ad-hoc reports for assigned projects
• Ability to work independently with minimal supervision
• Ability to manage multiple priorities and meet deadlines
• Ability to independently deliver system/process training and customer demonstrations as required
• Ability to build and maintain effective working relationships with colleagues and managers