Tarrytown, United States
12 months ago
The Clinical Database Engineer provides technical direction for the design, development, implementation, and verification of electronic data capture (EDC) requirements and electronic case report forms (eCRFs) within clinical data management systems at Siemens Healthineers. The role involves interfacing with clinical data managers, statisticians, clinical affairs representatives, and external partners and vendors to design, configure, test, implement, maintain, and execute changes to the clinical database systems. They will also be involved in troubleshooting any issues on behalf of users and maintaining data standards.
The position will report to the Director of Data Management within Medical, Biostatistical and Design Quality (MBDQ). Duties & Responsibilities: In conjunction with clinical study team, develops, implements, and tests requirements (key variables, CRFs, edit checks, etc.) for electronic data capture of clinical trial data Provides guidance and training to clinical affairs, statistical affairs, data management, and R&D Staff on EDC tools Maintains data standards and medical dictionaries within the clinical EDC system Maintains compliance to regulations (HIPAA, Data Protection Act, etc.) Develops reports to support study monitoring, data cleaning and verifications of data quality Manages user access and permissions within the clinical EDC system Monitors performance of the Clinical EDC and manages parameters to provide fast responses to front-end users Translates protocol requirements into requirements for EDC and/or eCRFs Ensures that the design decisions from end-users at trial sites, study monitors, biostatisticians, etc are implemented in database Required Knowledge/Skills, Education, and Experience Bachelors Degree in Science or Engineering 6+ years within clinical data management or software engineering support of EDC systems and applications At least 5 years experience with configuration, testing, and management of clinical or analytical studies within Clinical Data Management Systems (e.g. Medidata RAVE, Medrio, Oracle Clinical) Proficiency with the following programming languages: VBA, SQL. Knowledge and experience within Microsoft Office (Word, Excel, PowerPoint), Visual Studio .NET (C# or VB), SQL Server
Clinical Database Engineer Preferred Knowledge/Skills, Education, and Experience Masters degree in bioinformatics, Computational Biology, Computer Science (Relational Database Systems emphasis), or Software Engineering Experience with Laboratory Information Management Systems (LIS/LIMS) Knowledge of SAS or R Programming, data analysis, medical coding. Proficiency with the following programming languages: C#, ASP.NET, HTML