The Clinical Data Programmer provides advanced data management support to internal study and scientific teams. This is a technical role involving both advanced software capabilities and a strong understanding of good clinical data management practices. This position supports deployed software applications in a regulated environment and their use within Invicro Data Management and across other research areas of the organization.
- Develop data collection forms to maximize efficiencies in data acquisition across multiple imaging modalities and therapeutic areas.
- Provide internal Core Lab data analytics support to study teams and upper management
- Utilize analytic tools to program/generate summarization of study data to support study teams and overall scientific interests
- Define and implement new processes and workflows through cross-department collaboration
- Collect and design new software application requirements for development of software applications/modules. Communicate design requirements to software development personnel.
- Design and develop custom calculations, error checks, and automated data validation routines.
- Identify requirements and create customized reports from Core Lab systems for internal and external customers.
- Build data conversion paths and develop efficient and appropriate sponsor deliverable file formats, including CDISC SDTM and ODM compliance requirements
- Assist with the development of data integrations for continuity across internal data platforms (sites, sponsors, Invicro locations)
- Participate in software user requirement definitions and updates, representing comprehensive data management from data acquisition through the data reporting study lifecycle.
- Move internally developed technology forward and manage transition of historic data into new platforms
- Provide coaching, support and mentoring to less experienced team members in data management practices and related technical issues
- Support DM personnel in the development of technical documentation
- Advise on the development of database quality standards including the oversight of standard eCRF library and version control processes.
- Bachelor’s Degree in mathematics, computer science or equivalent demonstrated technical and analytical experience.
- Strong documentation and reporting capabilities.
- Detail oriented self-learner capable of training those in use of data analytics and data management practices.
- Possess strong written and verbal skills for effectively communicating with departmental staff and research centers.
- Experience implementing CDISC standards
- Strong understanding of GxP
- Expert level understanding of 21 CFR Part 11
- Median level SAS programing experience
- Experience with EDC (e.g. Open Clinica, RAVE, Inform, TrialMaster, etc.)
- Master level SQL proficiency
- 5+ years’ experience in data management
- Advanced development of data management tools, analytic software, internal software.
- Experience working with sponsors on complex data management and analytical outputs.
- Working knowledge of FDA Guidance Documents / EU Directives.
- Experience working with research data and clinical development support.
- Comprehensive understanding of the clinical drug and/or device development process
- Expert level SAS programming experience
- Experience with Alfresco software
- Additional languages Visual Basic, C#, Pearl, Python a plus
- Expert level understanding of XML and JSON code
- Previous experience in the entire data management life cycle with at least 1 large phase III study.