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Biometrics Business Analyst


Location: Waltham, Massachusetts
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Position Summary:

The Biometrics IT Business Systems Analyst serves as the technology business partner to support ad implement innovative process and system improvements to promote overall organizational efficiency and effectiveness. The role will be responsible for business requirements, business process definition/documentation, systems consulting, and system support management.

Position will work with all levels of the business including business partners, technology teams, and external vendors. Position will focus on business process documentation and business requirements, implementing and supporting Biometrics business solutions.  Biometrics business areas of focus include Clinical Data Management and Statistical Programming and Operations.

Key Responsibilities Include:

  • Represent IT as the business analyst and technical SME across the Biometrics busines areas.
  • Partner with Biometrics business areas to understand business needs and identify solutions that align to overall business strategies. Review, analyze and evaluate business systems and user needs.
  • Responsible for business systems consulting, project planning, prioritization, and implementation of deliverables, including implementations and operations.
  • Develop process documentation (current and to-be).
  • Document system, functional and business requirements, and objectives for clinical initiatives.
  • Technical SME for system activities for the clinical system(s), enhancements, and integration projects. Coordinates support activities across vendor(s).
  • Interfaces with multiple external vendors at all levels to manage the relationship and ensure the proper delivery of services.
  • Identify and troubleshoot operational issues and system issues.
  • Provide IT system support, including vendor operational and maintenance and oversight to the vendor’s SLAs.
  • Represents IT in collaboration with Quality Validation and business stakeholders to determine computer system validation (CSV) impact, requirements, and artifacts.
  • Executes and facilitates GxP Computer System Validation activities for IT, including implementation, validation, maintenance. 
    • Responsible for computer system validation and change control documentation including: System Assessments, Validation Plan, User Requirements and/or Specifications, Testing Protocols and Scripts (IQ/OQ/PQ/UAT), Traceability Matrix, Validation Summary Report
    • Support and maintain procedures and operational support processes for Biometrics business area systems

Education, Registration & Certification:

  • Bachelor’s degree in computer science, technology, operations, or related disciplines required.

Experience:

  • 7-10+ years in a pharmaceutical/biotech or related environment required
  • Experience with business process development and gap analysis, and business process mapping efforts.
  • Experience in working with software vendors for support and maintenance
  • Experience with GxP guidelines, Computer Software Validation (CSV), and IT SDLC
  • Experience with JMP, SAS Analytics, EDC and/or IRT solutions, Elluminate is preferred
  • Experience with Linux environments and Windows Remote Desktop (RDP) Solutions is preferred

Skills, Knowledge & Abilities:

  • Self-motivated and passionate to learn and adopt new technology and methodologies
  • Team-oriented and generous in sharing knowledge and enabling others
  • Reliable, consistent, and proactive
  • Capable of day-to-day problem solving and taking responsibility for decisions
  • Customer Service oriented with attention to detail and quality
  • Must be able to effectively prioritize and plan. Ability to address multiple projects and adapt to changing priorities.
  • Strong communication and facilitation skills to develop consensus, clarity, and decision-making
  • Ability to communicate and work independently with cross-functional/inter-departmental teams and within the framework of the IT organization.
  • Understanding of technical IT issues to enable discussions with internal and external technical specialist
  • Experience supporting heavily outsourced organizations and working with CROs/FSPs.
  • Experience defining and maintaining data transfer and/or data integration mechanisms in a hosted systems architecture; supporting an outsourced development model
  • Strong understanding and working knowledge of FDA 21 CFR Part 11, ICH E6(R2)
  • Strong understanding and working knowledge of clinical trials and GxP regulations (FDA, EMA)
  • Experience working in a GxP environment(s) is required
  • Proficient in Microsoft Word, Excel, PowerPoint and other applications.

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