Sr. Business Architect/Analyst

Location: Alexandria, VA

Req#: 473114
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Company Information
Job Description

Octo Consulting Group is seeking a Senior Business Architect / Analyst to join our growing team in Silver Spring. The Federal government needs requirements development and management support along with business analysis and planning support to include conducting requirements reviews, managing and tracing requirements, facilitating requirements workshops.

Responsibilities

  • Work with project delivery teams to provide leadership and analytical support in the execution of project approaches and development of deliverables and strategic recommendations to drive organizational improvements in business processes, program operations, strategic planning, policy effectiveness, and decision–making.
  • Perform independent quantitative and qualitative data collection and analysis methods on study data to derive insights on client issues, evaluate trends, and assess potential solutions.
  • Perform non-clinical and clinical study data profiling to analyze study data quality and identify data deficiencies impacting meaningful regulatory review and analysis, and propose enhancements to address source data deficiencies 

  • Lead analysis about current regulatory study data review practices and data processing systems and to identify future business needs for the study data analysis and business reporting.
  • Conduct storyboarding sessions with SMEs to identify and define relevant use cases that will support the collected requirements and ensure readiness for full production implementation.
  • Analyze non-clinical and clinical study data (including the study data life cycle and metadata layer), their characteristics and formats; 

  • Identify key study data concepts, document them and their relationships in the form of ontology, and derive from those concepts data element definitions and formats required by the FDA; 

  • Develop and support or lead communications of practical solutions to clients in the form of data–driven presentations, briefings, and reports.
  • Provide a strategy for the implementation of an Integrated Study Data Solution, outlining required major activities, document the proposed strategy in an implementation roadmap document. 

  • Applies requirements management best practices to facilitate, elicit, and analyze business and system requirements, create conceptual business models.
  • Ultimately responsible for the quality and comprehensiveness of all requirements artifacts, including the Business Requirements Document (BRD).
  • Facilitates requirements elicitation sessions with all levels of personnel.
  • Conduct alternative analysis for future study data validation tool set, including integration to the current FDA validation process.
  • Lead coordination with vendor partners for the development of prototypes and pilots.
  • Serve as a liaison between technical and business stakeholders by providing Requirements Management and Business Analysis.
  • Work with developers, subject matter experts, and stakeholders through the applications development lifecycle, integrating end-user training into the lifecycle.
  • Responsible for the development and delivery of end-user training as well as the development of training material to support a suite of custom software applications.
  • Produce training materials such as user guides, quick reference guides, instructional videos, and brown bag presentation materials.
  • Facilitate understanding of how the application supports a business process and interfaces with other applications within an organization.
Skills & Requirements
  • At least 10 years of post-collegiate professional experience
  • 1+ years of experience with the health or medical product industries, including R&D, clinical, regulatory, marketing, strategy, operations, manufacturing, or consulting
  • 2+ years of experience with strategy or management consulting
  • Experience with clinical and non-clinical data including:
  • CDISC Standard for Exchange of Non-Clinical Data (SEND) for non-clinical study
  • CDISC Study Data Tabulation Model (SDTM) for clinical data
  • CDISC Analysis Data Model (ADaM) for analysis of clinical data
  • CDISC Case Report Tabulation Data Definition Specification
  • Strong, proactive management consultant with customer relationship management, communication (written and verbal) and interpersonal skills
  • Understands conceptual business models and process flows
  • Experienced developing and reviewing Business Requirements Documents (BRD)
  • Experienced developing and maintaining training plans and materials
  • Technical expertise and ability to effectively explain technology to business stakeholders
  • Proficient with MS Office Suite (i.e., Word, Excel, Visio)

Preferred

  • Knowledge of medical product development and regulatory pathways
  • MA or MS degree in a life science–, engineering–, or health–related field or MBA degree preferred; PhD degree in life science–, engineering–, or health–related field a plus
  • Regulatory Affairs Certification (RAC)
  • Project Management Professional (PMP) Certification
  • Lean Six Sigma Certification

Location: 

  • On-site meetings, supports and operations shall be performed at 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993. Otherwise work will be performed in Alexandria, VA 

 

About Octo Consulting Group, Inc.

Octo Consulting Group (Octo) is an industry-leading, award-winning provider of digital services for the federal government. Octo specializes in providing agile software engineering, user experience design, cloud services, and digital strategy services that address government’s most pressing missions. Octo delivers intelligent solutions and rapid results, yielding lower costs and measurable outcomes.

Our team is what makes Octo great. At Octo you'll work beside some of the smartest and most accomplished staff you'll find in your career.  Octo offers fantastic benefits and an amazing workplace culture where you will feel valued while you perform mission critical work for our government.  Voted one of the region’s best places to work multiple times, Octo is an employer of choice!

Octo Consulting Group is an Equal Opportunity/Affirmative Action employer.  All qualified candidates will receive consideration for employment without regard to disability, protected veteran status, race, color, religious creed, national origin, citizenship, marital status, sex, sexual orientation/gender identity, age, or genetic information. Octo Consulting Group’s commitment to diversity and inclusive selection practices includes ensuring qualified long-term unemployed job seekers receive equal consideration for employment. 

Other Considerations: This position is W-2 only; no Corp-to-Corp or 1099 candidates.Relocation will not be offered. Selected applicants will be subject to a background investigation. Individual’s primary workstation is located in an office area. The noise level in this environment is low to moderate. Regularly required to sit for extended periods up to 80% of time; frequently required to move about to access file cabinets and use office equipment such as PC, copier, fax, telephone, cell phone, etc. Occasionally required to reach overhead, bend, and lift objects of up to 10 lbs. Specific vision abilities required by this job include use of computer monitor screens up to 80% of time.

For more information please visit: 

www.octoconsulting.com

www.octoconsulting.com/careers