The Department of Neurology is seeking a Sr. Software Engineer with a strong programming background to support the Brain Injury Outcomes Services (BIOS) Research Program and Clinical Trials Unit, which manages multi-center, $20+ million dollar federally funded clinical trials and multiple site-specific pharmaceutical sponsored trials. This position is responsible for leading and performing database programming and system integration across platforms for the entire life cycle of clinical trials, especially the creation, implementation, maintenance, performance, production support, and documentation of various application systems. This includes, but is not limited to, electronic data capturing systems (EDCs), databases, data visualization tools, file repository, cloud-based API connections, and web applications. Applies analysis techniques and procedures to gather and then translate business requirements into functional/technical specifications and designs. Using functional specifications and designs, produces all or part of the deliverables. Maintains databases and application code.
This position will routinely interact with clients, typical clients supported are research investigators, research administrators, engineering teams of partner vendor software companies, faculty, research staff, technologists, and trainers. Depending on the task and project involved, the position may be expected to lead, develop team members from the Data Coordinating Center, work as part of a team, or work individually to complete the work as necessary. The position should be comfortable carrying out tasks with limited guidance.
While the primary focus will be on software and software engineering, this position will play a critical role in the design and direction of the overall projects, determining how to turn leadership vision into practical implementation while utilizing a team of data managers and data programmers to complement the project efforts.
Specific Duties & Responsibilities
- Responsible for leading, performing, and overseeing clinical data management in all phases, with a focus on design, development, implementation, and support of systems maintained by BIOS, including study EDCs, databases, and performance tracking tools.
- Perform end-to-end clinical data management activities during study start-up, study conduct, and study close-out according to regulatory requirements and SOPs.
- Review study protocol; develop and program study case report forms with the study team for online cloud-based implementation.
- Lead the design, development, and maintenance of systems to match stakeholder requirements, including study EDCs and other tools.
- Provide ongoing maintenance, support, and enhancements in existing software systems.
- Create technical documentation including, but not limited to system specifications, design documents, maintenance/configuration guides, user acceptance test plan, user training manual, and SOPs.
- Work closely with division leadership, project managers, analysts, statisticians, customers, and project team to scope, estimate, build, and deploy quality solutions.
- Work with vendors to resolve problems as needed.
- Lead portions of large tasks or projects.
- Maintain familiarity with installed software standards and procedures and evaluate other tools to determine the appropriate fit into application development.
- Conduct peer reviews including design and code reviews to learn and consistently apply standards and best practices.
- Develop data processing pipelines, dashboards, study progress reports, safety reports, key risk indicators, and other ad hoc reports to support analysis of trial meta-data and trial innovation.
- Screen potential data management candidates and conduct interviews.
- Develop staff training materials and plans for long-term development.
- Onboard and train new team members.
- Assign appropriate team members to projects according to their knowledge and skill levels.
- Oversee development, update, and maintenance of all BIOS applications, including 10+ study EDCs, multiple tools developed for internal management, multiple study websites, etc.
- Provide expertise and give presentations during consultations with potential clients.
- Lead the development of electronic data capture systems for multicenter, clinical research trials.
- Design, develop, and maintain SQL server data warehouse.
- Develop ETL solutions to integrate various data sources (XML, JSON, flat files, SAS files, etc.) into one consolidated data repository.
- Use statistical and visualization tools to develop reports, metrics, and dashboards.
- Develop and manage interactive websites for division and research studies.
- Make recommendations for software, hardware, and data storage upgrades.
- Analyze business procedures and create IT solutions to improve operation.
Minimum Qualifications
- Bachelor's Degree.
- Six years of related experience, with experience in clinical research.
- High level of proficiency in SQL, Python, and R.
- Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula.
- Direct programming experience while pursuing education may count towards related experience. Significant undergraduate programming coursework or independent project can be considered as related experience.
Preferred Qualifications
- Master’s Degree in Information Systems, Computer Science, Computer Engineering, Software Engineering, or closely related field.