Senior Business Systems Analyst
Bethesda, MD
The Senior Business Systems Analyst, under limited direct supervision, is responsible for planning and directing the analysis of complex business functions to be addressed with automated solutions. The Senior Business Systems Analyst is instrumental in all phases of the software development lifecycle (SDLC), and collaborates with:
- business stakeholders to document requirements and use cases
- application developers and system architects for solution design and system integration testing
- business and technology stakeholders to plan and support the implementation of automated systems.
The Senior Business Systems Analyst provides end-to-end analysis support for one or more projects in parallel, and may lead cross-functional teams to address business needs with systems and procedures that meet requirements in a cost-effective manner. The Senior Business Systems Analyst, as part of a project team, is accountable for project objectives set together with the project manager and technology director, and collaborates with them to ensure successful delivery.
Responsibilities:
Business Systems Analysis and Implementation:
- Develops subject matter expertise in Cardiocore’s systems in order to provide guidance on available functionality to business users
- Gathers and documents functional requirements and use cases for automation of Cardiocore operational and administrative business processes
- Translates requirements into system requirements specifications
- Participates in the identification and selection of software applications
- Supports study project managers in gathering and documenting requirements for customer or study-specific requests
- Collaborates with Application Development or external software providers to deliver adaptive solutions to meet customer or study-specific requests
- Coordinates with Application Development and external software providers to document solution design, and to ensure that their deliverables meet the requirements and are tested
- Facilitates resolution of functional points of contention between business users and technology developers
- Develops and documents test scenarios and test cases for computer system validation
- Provides functional walkthroughs with internal and external customers, testing teams and Application Support
- Guides and advises less experienced Business Systems Analyst(s)
- Provides input to training materials for users on new or upgraded applications
- Teams with Application Support to prepare for production implementation and on release management
Business Process Analysis and Design:
- Studies, analyzes and documents process flows of business activities
- Translates process flows into use cases
- Develops subject matter expertise in Cardiocore’s business process management (BPM) tools in order to modify existing or set up new process definitions
- Manages implementation of technology-enabled processes, working in partnership with other internal groups
Standard Operating Procedures and Regulatory Compliance:
- Produces deliverables in compliance with Software Development Life Cycle (SDLC) Standard Operating Procedure (SOP), Work Instruction Documents (WIDs)
- Coordinates with Regulatory Compliance on documentation of SOPs, WID based on BPM system output
- Provides input on SDLC procedures and document templates for continuous improvement
- Supports customer audits to provide overview of processes, SOPs, WIDs as requested
Experience:
- Five (5) to eight (8) years experience in business systems and process analysis and documentation, preferably in a FDA-regulated clinical research environment (CRO, pharmaceutical or biotech)
- Demonstrable experience in effective verbal and written communications, and interaction with internal and external customers at all levels
- Experience with all phases of the software development lifecycle, applied to commercial off-the-shelf (COTS) and bespoke software
- Experience with multiple software development life cycle (SDLC) methodologies such as Agile and Waterfall
- Business process design/redesign and data analysis experience for operational and administrative processes
- Familiarity with computer systems validation requirements and methodologies a plus
- Familiarity with applicable regulatory guidance and rules, e.g., 21 CFR Part 11, FDA guidance, GCP, ICH E14
Education:
- BA/BS or Master’s degree in information technology or a business discipline
Skills:
- Superior verbal and written communications and presentation skills
- Strong organization skills; thorough and detail-oriented
- Excellent business writing skills for documenting business requirements, use cases, functional specifications, design specifications and test cases
- Proficient in using common industry methods and tools, such as UML, for Business Process Modeling, Use Cases, Activity-Sequence Diagrams, Data Flow Diagrams, Collaboration Diagrams, Class Diagrams
- Use of tools such as Microsoft Visio for User Interface (UI) design and Business Process Management Notation (BPMN) for Business Process Modeling
- Knowledgeable about object-oriented analysis and design concepts, system architecture, relational database design, data and file structures
- Familiarity with systems platforms and tools used in development of web-based applications, such as Microsoft .NET, Web Services (SOAP, WCF, WSDL), J2EE, Terminal Services, IIS, Apache Tomcat
- Proficient in use of computer systems and tools, including Microsoft Office applications such as Project, Visio, Excel, Word, PowerPoint
- Ability and willingness to travel (<10%)
(EOE)
Principals Only