• Bachelor’s degree required or equivalent in experience
• Advanced knowledge of computer programs (e.g., MS Word, MS Excel, computerized data acquisition systems).
• Knowledge of laboratory operations, study design, and equipment used in the department.
• Detailed knowledge of business processes and detailed knowledge of main data collection and analysis applications (i.e. NG/Pristima and Tox Reporting).
• Knowledge of GXPs and regulatory agency guidelines.
• Knowledge in the management of small business projects.
• Fluent English
• Highly competitive salaries
• Great opportunity for career growth
• Flexible work schedule
• Comfortable office in the city center
• International teams experience, business trips (Germany / US)
• Career and professional growth
• Social package (health insurance, conference/educational expenses cover)
• The position will function on a regional level and global level.
• Act as Subject Matter Expert for any automation they have developed/supported.
• Provide technical troubleshooting support and issue resolution for assigned computer applications and associated instruments.
• Lead and co-ordinate resolution to technical and business process issues as related to assigned automation.
• Liaise with Business Analysts on a regular basis to ensure the smooth and appropriate transition of new process automation.
• Document discussions, issues, recommendations, and resolutions related to supported automation.
• Communicate technical issues and resolutions and share information with the Automation team.
• Understand and maintain a high level of functional subject matter expertise and help to manage changing requirements.
• Work with Business Analyst to fine-tune functionality.
• Recommend optimization of business processes and automation functionality.
• Perform other related duties as assigned.
• Understand and follow regulated software development process as it applies to automation development.
• Validate, perform and document unit testing of the automation.
• Participate in and sign-off of code review and documentation.
• Validate and perform user testing including the process design tests to challenge the software, and documenting results/installations as required by SOPs.
• Write, approve, and perform qualification and other testing required to ensure automation functionality
• Archive validation documentation.
• Create, manage, and archive automation documentation.
• Develop efficient and effective processes process automation.
• Support developed automation in production.
• Maintain automation configurations which can be controlled within the Blue Prism platform.
• Assist in retirement and/or decommissioning of automation, if necessary.
• Assist in the coordination of release of new versions of the automation into production including completing the Release into Production Checklist.
• Verify the installation and operation of the automation in production.
• Document analysis and/or testing related to infrastructure or host application changes.
• Participate in validation projects for assigned automation (e.g. requirements analysis, validation, and regression testing, process analysis, deployment).
Quartesian in a nutshell: 400+ people worldwide. HQ in Princeton, NJ. 16+ years of growth. 165+ pharma companies as clients. 850+ clinical trials processed. Key services & products: data analysis and reporting for clinical trials; outsourcing software development and own data-driven products.
We offer to join our team providing statistical support in different cases: functional service providing for the world’s largest CROs and pharma companies, multitudes of various internal projects, work on automation tools and even a chance to try working in adjacent professions (business analyst, data science, etc.)
Kyiv team currently consists of 60+ statistical programmers, biostatisticians, software developers and data scientists.