JVT Advisors

Business Analyst, Clinical Medical Systems

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Location: Cambridge, Massachusetts
Employment Type: Contract

Job Description

Contract Length:  6+ months

Job Summary:    As a Business Analyst, you will be spearheading the execution of critical digital projects in support of the company’s ambitious clinical digital roadmap. In this role, you will connect and lead various stakeholders and contributors to collaborate on digital clinical projects.

  • Coordinate and participate in requirement gathering and definition (Business Analysis) for Clinical Data Environment (CDE) – Data Checks and Cleaning, Conformed Data Store, and Statistical Computing Environment (SCE) projects
  • Establish and manage project timelines and project deliverables.
  • Ensure project goals and means meet business objectives and deliver value in a timely
  • Work collaboratively across the organization to gain alignment on project objectives and deliverables.
  • Engage with Computer Systems Validation lead to support appropriate validation activities.
  • 7+ years' experience in digital project management/business analysis in a GxP environment
  • Proven experience with numerous Clinical Data Management Systems (e.g, Medidata Clinical Cloud, eLluminate, Saama SDQ, etc.) and external clinical data sources (e.g., Lab, biomarker, eCOA, DTC, etc.)
  • Working knowledge of CSV concepts for SaaS GxP applications
  • Working knowledge of AI/ML model validation process
  • Tangible track record in using Agile approaches in a regulated environment
  • First-hand knowledge of SaaS technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials.
  • Working knowledge of clinical operations, clinical data management, regulatory and safety business processes in a drug development context
  • Bachelor's degree in Computer Science, Biotechnology or equivalent required. Master's preferred.

Ovrille Gonsalves

Director of Recruiting & Training

Ovrille is responsible for full lifecycle recruiting for JVT’s clients across several industry verticals. He supports the Contract Recruiting team, and specializes in identifying temp (contractual) and temp-to-perm resources for JVT’s clients.

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