Performs user acceptance and/ or validation of clinical database build tasks according to applicable SOPs (standard operating procedures) and processes.
Drive study database user acceptance testing activities in an individual contributor role that requires leadership across multiple therapeutic areas and the ability to partner closely with internal/external stakeholders to ensure the quality of the study build in the EDC system.
Collaborate with various vendors and cross functional teams to build to ensure accuracy of any integration.
Ensure accurate delivery of study build with quality deliverables per specification. Participate in the development, maintenance and training rendered on activities around study build and best practices used by business.
Network with key business stakeholders on refining and enhancing the activities around study to automate the study build and reduce the need for testing.
Develop organizational knowledge of organizational clinical data standards, key data sources, systems and be a valuable resource to people in the company on how to effectively automate study build to pursue company objectives. Provides technical leadership on various aspects of clinical data flow including build APIs to various systems for data extraction and integration.
Performs user acceptance testing for data checks, core setup, and/ processes for various peripheral systems
Coordinates the activities of external vendor personnel that might assist in testing to ensure all jobs are carried out and timelines are met.
Provides basic technical support / consultancy, end-user support, works with IT in troubleshooting, reporting, and resolving system issues.
Actively communicate with the management team and clinical teams regarding testing activities. Participate in frequent teleconferences and emails with clinical research institutions and vendor partners. Demonstrate diplomacy and patience in working to achieve common goals.
Requirements :
Bachelor's degree in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job.