Application System Analyst

Location: Alexandria, VA

Req#: 473116
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Company Information
Job Description

Octo Consulting Group is seeking an experienced Application System Analyst to join our growing team in support of a Federal customer. The Application System Analyst will perform testing and lead other testing resources.

Responsibilities

  • Conducting assessments, ongoing audits, provide remediation and recommendations.
  • Preparing reports concerning failures in compliance and ways to remediate
  • Reviewing compliance defects with developers and discuss possible resolutions
  • Monitoring resolution of compliance violations
  • Develop and deliver recommendations for configuring the COTS Tool to support the eSubmissions process
  • Collaborate with the client and vendor partner to evaluate product capabilities and limitations
  • Perform gap analysis to identify any additional COTS Tool shortcomings and weaknesses that may impact successful COTS tools transition and perform root cause and impact analysis and technical evaluation of these shortcomings.
  • Work with client, the COTS Tool vendor, and stakeholders to perform independent acceptance testing of the new COTS tools to validate conformance to the eCTD 4.0 format. 

  • Work with client, the tool vendor, and stakeholders to develop a change management plan which defines activities to manage and control implementation of change requests.
  • Develop, implement, and maintain technical test, quality assurance and control systems.
  • Work with the client, the tool vendor, and stakeholders in preparation of test plan, test scripts, and test data covering all validation rules specified in the requirements and specifications.
  • Supporting configuration of associated toolsets to support automated and manual test cases
  • Supporting test cases and procedures development with traceability to customer requirements and executing the tests to include support for test readiness events, defect identification and fault isolation; and status reporting on test events.
  • Facilitating testing improvements by recommending best practices, supporting other testers and sharing knowledge of test tools.
  • Writing test cases, scripts, and code for unit/functional tests.
  • Work with developers, subject matter experts, and stakeholders through the applications development lifecycle, integrating end-user training into the lifecycle.
  • Support the development and delivery of end-user training as well as the development of training material to support a suite of custom software applications.
  • Maintain 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
  • BA/BS Bachelor’s Degree and a minimum of five (6) years of professional experience
  • Perform unit testing, regression testing, integration, systems and UAT activities
  • Develop, maintain, and upgrade automated test scripts and architectures for application products.
  • Write, implement, and report status for system test cases for testing.
  • Analyze test cases and provides regular progress reports.
  • Experience in root cause analysis and defect diagnosis techniques. Ability to document software defects, and report defects to developers and project manager.

Preferred Skills

  • Knowledge of FDA regulatory requirements
  • Experience with Lorenz Life Sciences Group software products including eValidator, Automater, and docuBridge.
  • Understanding of the ICH eCTD 4.0 (and earlier versions of the standard)
  • Experience with GlobalSubmit eCTD software product
  • Experience transitioning to eCTD versions
  • Regulatory Affairs Certification (RAC)
  • 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

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