Clinical Operations Application Support Specialist

Managed Services - Kosice

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Your profile / requirements

• Bachelor’s or higher degree in a scientific discipline (e.g. computer science, information systems, engineering, mathematics, natural sciences, medical, or biomedical science) 
• Knowledge of systems in the Clinical Operations domain, incl. eTMF and CTMS systems with demonstrated experience in managing support and demand needs for these systems 
• 2+ years of relevant experience in Clinical Operations business domain, Clinical Operations business processes, and Data Management 
• Ability to understand complex functional requirements/requests from business users and translate them into pragmatic and workable (technology) solutions 
• Strong agile process management mindset and ability to provide customer-facing support to identify value drivers and continuous improvement of processes and solutions 
• Experience with one or more of the following systems is desired: Veeva (Veeva Vault Clinical, eTMF, CTMS) or comparable software  Nice to have: 
• ITIL knowledge and certification 
• Veeva certification 
• Technical skills and deep functional knowledge of the processes and business operations in the Biopharma R&D domain Understanding of working in GxP environment 
• Technical overview and understanding of OS, Cloud infrastructure, Databases (SQL queries), Middleware, Network, Storage and Backup  
• Experience with:  Release & Deployment Management, License management, Proactive monitoring of applications and jobs, Outage management, Application Documentation  
• Experience with one or more of the following systems is nice to have: TIBCO Spotfire (preferably Exploratory platform) , Lorenz docuBridge,  Generis CARA , Userlane (Engagement Suite, Heart Analytics) , Elluminate (eClinical Solutions) , EGNYTE,Metworx , PleaseReview (Ideagen), SAS 

Tasks and responsibilities

• Provide application support to key users for Veeva clinical operations platforms, covering business functional operations, high-level data analytics, and change management. 
• Manage Incident Management, Service Request support, and Problem Management to resolve issues efficiently. 
• Lead Operational Change & Configuration Management, including system updates and validation processes. 
• Support system data management activities such as master data management, ensuring data quality, security, and integrity, and implementing data-related changes. 
• Serve as a technical liaison between operative master data handling, business units, and regulatory units. 
• Develop and maintain User Requirement Specifications and Quality Control documentation in line with SOPs and processes. 
• Analyze solution releases, align on process and data requirements, and author/execute test scripts. 
• Conduct business operations impact assessments and implement industry best practices. 
• Proactively engage the user community to ensure readiness for new regulatory and technical changes in Veeva Vault Clinical systems. 
• Collaborate with IT teams and external vendors to troubleshoot technical issues and coordinate updates. 
• Drive continuous improvement processes to enhance system functionality and user satisfaction. 

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