Project Manager/Business Analyst, Technology Development
Rockville, MD
The Project Manager, under limited direct supervision, is responsible for planning and directing the analysis of business functions to be addressed with automated solutions, and managing their development and transition to deployment. The Project Manager is instrumental in all phases of the software development lifecycle (SDLC). The Project Manager provides end-to-end analysis and project management 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 Project Manager is accountable for project objectives set together with the technology director and the business stakeholders, and collaborates with them to ensure successful delivery.
Responsibilities:
Business Systems Analysis
- Collaborating with:
business stakeholders to document requirements and use cases
application developers and system architects for solution design and testing
Regulatory Compliance to develop user test cases for computer system validation, as required - Providing functional walkthroughs for internal and external customers, testing teams and Application Support
- Providing input to training materials for users on new or upgraded applications
- Coordinating with Application Support to prepare for production implementation and on release management
Project Management
- Applying project management principles, concepts and techniques for effective project management, including quality assurance and customer satisfaction
- Organizing, directing, and coordinating planning and delivery of all mutually agreed project activities
- Developing project plan, schedule, deliverables, dependencies and resource requirements
- Managing cross-functional teams of internal and external resources
- Identifying, documenting and communicating project risks and contingency plans.
- Tracking and communicating project status, issues, timelines, action items, and budgets
- Managing project scope
- Collaborating with:
business and technology stakeholders to plan the testing and implementation of automated systems
Production IT to transition the solutions to successful deployment - Conducting quality assurance review of project deliverables and documentation
Standard Operating Procedures and Regulatory Compliance
- Producing deliverables in compliance with Software Development Life Cycle (SDLC) Standard Operating Procedure (SOP), Work Instruction Documents (WIDs)
- Providing input on SDLC procedures and document templates for continuous improvement
- Supporting customer audits to provide overview of processes, systems as requested
Experience:
- Five (5) to eight (8) years experience in project management and business systems 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
- Demonstrable experience in project management discipline and processes
- 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
- Proficient in use of computer systems and tools, including Microsoft Office applications such as Project, Visio, Excel, Word, PowerPoint
- 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
- 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
Travel:
- Ability and willingness to travel (<10%)
(EOE)
Principals Only