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Katalyst CRO

Clinical Test Lead (Boston)

Katalyst CRO, Boston

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  • Lead and mentor high-performance teams of Test Analysts/ Engineers, in geographically distributed locations, effectively to deliver testing-related project deliverables on time, on budget, and with high quality.
  • Effectively leverage test automation techniques and technologies to reduce cycle times and provide high levels of test coverage.
  • Ensure company processes are continuously followed, refined, and improved upon. Execute all activities following organizational controls and processes (Good Clinical/Manufacturing Practices (GxP), Software Development Lifecycle (SDLC), Change Management (CM), etc).
  • Translate business requirements to create test/validation strategy and plan, design and execute test cases, coordinate test activities with development and business team members, create and report periodic reports (test and defect reports, traceability matrix), manage defects, and ensure resolution.
  • Manage/Own test/quality-related communication, documentation, and delivery of user training as needed. Stay abreast of best quality/testing practices across the Business Process Automation Space.
Responsibilities
  • Lead and mentor high-performance teams of Test Analysts/ Engineers, in geographically distributed locations, effectively to deliver testing-related project deliverables on time, on budget, and with high quality.
  • Effectively leverage test automation techniques and technologies to reduce cycle times and provide high levels of test coverage.
  • Ensure company processes are continuously followed, refined, and improved upon. Execute all activities following organizational controls and processes (Good Clinical/Manufacturing Practices (GxP), Software Development Lifecycle (SDLC), Change Management (CM), etc).
  • Translate business requirements to create test/validation strategy and plan, design and execute test cases, coordinate test activities with development and business team members, create and report periodic reports (test and defect reports, traceability matrix), manage defects, and ensure resolution.
  • Manage/Own test/quality-related communication, documentation, and delivery of user training as needed. Stay abreast of best quality/testing practices across the Business Process Automation Space.
Requirements:
  • Minimum of 8 years of software quality testing experience and 12+ years of IT/Industry experience.
  • 5+ years of experience in Computer Systems Validation (CSV) in the context of Good Clinical/Manufacturing Practices (GxP) is preferred.
  • Experience with software application test planning and functional testing, performance testing, developer management, and defect management using Application lifecycle management (ALM) tools.
  • Experience with automated testing and continuous integration/development (CI/CD) frameworks is preferred.
  • Experience with test data management and processes analysis, and documentation experience (using industry standard tools).
  • Experience with scrum/agile or other project management methodologies.
  • Experience with process improvement disciplines is preferred.
  • Knowledge/Experience in the life-sciences/biotech space is preferred.
  • Excellent written and verbal communication skills.
  • Strong experience testing and leading UI, web-based, and mobile app testing teams.
  • Experience testing applications in the Research and Development domain, such as Safety, Pharmacovigilance, Regulatory, Clinical Trial Management, Discovery, and Data Science.
  • Experience testing or leading testing for Veeva Vault applications is a strong plus.

Seniority level

  • Seniority level

    Mid-Senior level

Employment type

  • Employment type

    Contract

Job function

  • Job function

    Health Care Provider
  • Industries

    Pharmaceutical Manufacturing

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