Bethesda Categories:
Project Manager/Business Analyst, Technology Development Cardiocore Lab
THIS JOB HAS EXPIRED
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 Masters 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 (
| Location: | 6901 Rockledge Drive Suite 700 Bethesda, MD 20817 United States |
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THIS JOB HAS EXPIRED
Cardiocore Lab
Investors: Aperture Venture Partners, Maryland DBEDAll Jobs: at Cardiocore Lab
| Web Site: | www.cardiocore.com |
|---|---|
| Headquarters: | 6901 Rockledge Drive Suite 700 Bethesda, MD 20817 United States |
| Industry: | Healthcare Services |
