Job Description

The Department of Neurology is seeking a Sr. Software Engineer with 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 recommendation for software, hardware, and data storage upgrades.
Analyze business procedures and create IT solutions to improve operation.


Scale/size of area, project and/or system supported

Systems supported are utilized across the division and research consortiums and are responsible for processing thousands of data points and research related transactions.
These systems support a diverse and evolving clinical research and regulatory space to which compliance is critical.


Analysis and requirements gathering

Define moderately complex business/clinical research/training problems by meeting with teams to observe and understand current processes and the issues related to those processes.
Provide written documentation of findings to share with the trial teams and suggested solutions to implement when appropriate.
Gather moderately complex system requirements by meeting with clients and researching existing technology to understand the business requirements and possible solutions and cost effectiveness for new applications in an effort to continue to explore the best solutions for clinical trials.


Implementation & maintenance

Implement changes by adhering to the change management policies and procedures for any given project to communicate to all parties the nature, significance, and risk factors of the solution.
Monitor changes and resolve moderately complex problems by responding as they occur, by reviewing all processing and output of the newly implemented solution, and by proactively ensuring the solution works successfully in order to satisfy the project requirements and to provide a smooth transition to the new solution if applicable.
Provide support by triaging and independently resolving moderately complex issues.


The responsibilities listed are typical examples of the work performed by this position. Not all duties assigned to this position are included, nor is it expected that everyone in this position will be assigned every job responsibility.



Additional Knowlege, Skills & Abilities

Motivated and excited to learn: Our group often finds itself on the leading edge of software tools and methodology in the clinical trial operations and innovations arena.
Able to adapt to new environments, approaches, tools and, when necessary, able to extend an existing tool for a new purpose or, if necessary, develop an entirely new approach to solve a problem.
Self-directed: Able to set own schedule and goals but, at the same time, is willing and able to ask for guidance and assistance when uncertainty arises.
Able to take leadership vision and design and implement solutions.
Willing to implement the highest level of rigor in development, production, and monitoring of the data solution and its usability to ensure regulatory compliance and Good Clinical Practice (GCP) principles.


Minimum Qualifications
Bachelor's Degree.
Six years of related experience.
Clinical research experience required.
High level of proficiency in SQL, Python, and R required.
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.


Preferred Qualifications
Master’s Degree in Information Systems, Computer Science, Computer Engineering, Software Engineering, or other closely related field.