JVT Advisors

Project Manager, Digital Clinical Systems

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length: 9+ months

Job Summary: This individual will be spearheading the execution of critical digital projects in support of the company’s ambitious clinical digital roadmap.

Responsibilities:

  • Define and lead Digital Clinical, Medical & Regulatory Projects
  • Coordinate and participate in requirement gathering and definition (Business Analysis)
  • Establish and manage project timelines and project deliverables
  • Ensure project goals and means meet business objectives and deliver value in a timely fashion
  • Work collaboratively across the organization to gain alignment on project objectives and deliverables
  • Engage with Computer Systems Validation lead to support appropriate validation activities
  • Report on project progress and status

Requirements:

  • 7+ years' experience in digital project management in a GxP environment
  • Proven experience with numerous Clinical, Medical Affairs Regulatory (Veeva preferred).
  • Working knowledge of CSV concepts for SaaS GxP applications
  • Tangible track record in using Agile approaches in a regulated environment
  • Knowledge of SaaS technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials.

Christian Griffith

Recruiter

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