JVT Advisors

Senior Business Analyst - Clinical

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Location: Cambridge, Massachusetts 02142
Employment Type: Contract

Job Description

Contract Length: 6+ months (likely to extend)



You will oversee Clinical Development projects supporting compliance remediations and system retirements. You’ll have a critical role in the health and success of projects within a matrixed organization and have direct relationships with various business and IT groups.


Keys to the Role

  • High competency in system retirement and compliance remediation projects
  • Demonstrate traceable business and functional requirements (show work examples)
  • Monitor, manage, and ensure predictable delivery of the project in a deadline-driven environment.
  • Early identification and appropriate escalation of risks and issues that require assistance, attention, or executive resolution
  • Develop GxP-compliant SDLC deliverables
  • Perform risk assessments
  • Assist Test Lead validate functional requirements, where needed
  • Co-develop IT Support documentation (System Management SOP; Knowledge Base)
  • Provide status reports


What You’ll Bring

  • 5+ experience as a Business Analyst, including in a GxP environment
  • Knowledge of:
    • GxP
    • System Validation
    • NIST and Regulatory testing
    • Data Privacy guidelines.
    • CFR 21 Part 11
  • Strong knowledge of SDLC
  • Ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors
  • Excellent interpersonal skills to gain understanding of requirements and priorities, manage stakeholder expectations, recognize non-communicated requirements and bring them to light
  • Clinical Development - Biometrics and Data Management experience preferred.
  • The following are a PLUS: SAS, Data Hub, electronic data archiving



Zack Lisien

Technical Recruiter

Zack uses traditional and digital resources to keep our talent pool brimming with highly skilled and qualified technology innovators searching for opportunities.

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