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)

 

JOB SUMMARY

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

 

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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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