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Clinical Trial Consultant

SSi People

Cambridge, Massachusetts, United States Full-time July 02, 2026
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Vacancy Description

Job Title: Clinical Trial Consultant
Location: Cambridge, Massachusetts (Hybrid)

Job Summary: We are seeking a dedicated professional to support the processing and quality control of clinical trial and postmarket safety cases within a dynamic environment. Our team values precision and timely delivery to advance safety operations and ensure regulatory compliance.


Responsibilities:

  • Process, intake, and perform quality control for Individual Case Safety Reports (ICSRs) from clinical trials and assigned postmarket cases.
  • Draft narratives, code cases using MedDRA, generate follow-up queries, and notify stakeholders of significant safety events.
  • Conduct retrospective quality checks to ensure accuracy and consistency of processed cases and maintain on-time case completion for regulatory reporting.
  • Collaborate with Data Management to resolve reconciliation issues, investigate late regulatory submiss...
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