The Senior 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.
They will act as technical expert for the clinical data management system. The senior clinical database engineer will provide technical guidance, direction, and training to data management, clinical affairs, and statistical affairs staff on data management practices and database systems. They will provide technical oversight to the activities of junior clinical data management staff or contractors. They will serve as a prime point of technical contact and interface for database vendors.
The senior clinical database engineer will be responsible for maintaining knowledge of state-of-the-art clinical data management practices. The role will be expected to pro-actively identify issues and opportunities with current clinical data management processes and systems. They will provide input to senior management on process improvement and long-term strategies for clinical data management.
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
Makes design decisions with input from end-users at trial sites, study monitors, biostatisticians, etc
Required Knowledge/Skills, Education, and Experience
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
At least eight (8) years within clinical data management or software engineering support of EDC systems and applications
Working knowledge within areas of Good Clinical Practices, Good Clinical Data Management Practices, Design and Conduct of Clinical Trials/Studies, and related regulatory requirements and terminology
Experience working within a Clinical EDC system (e.g., Oracle Clinical, Medrio, Medidata Rave)
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
Exposure to clinical data coding classification systems, e.g., MedDRA, WHO-Drug, Data Standardization (CDISC STDM &/or ADAM), Metadata Repository (MDR)
Programming knowledge of SAS, R, &/or SQL is desired
Strong interpersonal, organizational, and communication skills
Excellent attention to detail and problem-solving skills
Ability to work effectively work in a team setting
Job ID: 188433
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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