Senior Business Analyst

1 day ago


Cambridge, Massachusetts, United States Verista Full time
Senior Business Analyst

At Verista, we're committed to empowering growth and innovation within the scientific community. As a Senior Business Analyst, you'll play a critical role in solving complex business needs for our clients in the life science industry.

Key Responsibilities:

  • Plan and develop business requirements and user stories in support of our DevTech products.
  • Act as a primary subject matter expert for teams using assigned products, including Clinical Data Lake.
  • Author and refine system support processes, operational procedure documents, flow diagrams, configurations, and interdependencies.
  • Partner with testing teams to draft and review UAT scripts and manage the end-to-end UAT process.
  • Effectively translate business requirements into user stories and supporting documents for agile development teams.
  • Support product owners in aligning with business system owners to prioritize product backlogs.
  • Participate in demand management processes to assist businesses in establishing business cases for new systems or potential system changes.
  • Complete upgrades and enhancements to existing applications.
  • Ensure compliance with regulatory requirements and controls related to business systems and IT infrastructure.
  • Independently deliver projects and initiatives in a timely and qualitative manner.
  • Highlight potential risks and act proactively to resolve issues.
  • FOLLOW company and departmental policies, procedures, and ensure documentation according to the Client Quality Management Systems (QMS), Software Development Life Cycle, and Project Life Cycle standards.
  • Work independently with stakeholders to prioritize requirements and be a primary resource on complex issues within a clear framework of accountability.
  • Establish relationships with colleagues across Takeda and analyze issues, guiding the development of solutions within ongoing processes.
  • Build and maintain relationships with key business stakeholders.

Requirements:

  • Experience working in R&D and/or Biotech preferred.
  • Working knowledge of clinical data systems, including EDC, Clinical Data Management systems, eCOA, IRT, Statistical Analysis Environments, CTMS, and eTMF.
  • Experience working with global teams remotely.
  • Bachelor's degree or equivalent in a science discipline or related field.
  • 7-10 years of pharmaceutical industry or related experience in implementing Clinical solutions.
  • Working Knowledge of managing requirements for AWS Cloud solutions and related services in Clinical data space.
  • Proficient knowledge of Quality Process Assurance/Compliance, 21 CFR Part 11, and other regulations (GXP) required.
  • Proficient in working within an SDLC framework (Delivery, Testing, Software Quality Assurance, Change Management).
  • Hands-on Agile tools like Atlassian Suite (JIRA/Confluence).
  • Ability to articulate complex technical problems and solutions to a wide business audience and communicate solution value.
  • Familiarity with change control and SDLC associated with computer system validation processes.


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