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AI Clinical Trial Protocol Deviation Detector

Bolvex Solutions

On-site · $130k – $160k / year · Full-time · Posted 3 months ago

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About the role

Our clients include Fortune 500 pharmaceutical sponsors running multi-site trials where a single undetected protocol deviation can jeopardize a submission. Reliability and auditability are non-negotiable here. This role builds statistical monitoring that flags deviations — missed visit windows, dosage inconsistencies, unauthorized concomitant medications — across sites in near real time, well before a routine audit would ever catch them.

Responsibilities

  • Build statistical monitors flagging protocol deviations across trial sites
  • Reduce time-to-detection for dosage and visit-window inconsistencies
  • Produce audit-ready documentation for regulatory submissions
  • Work on-site with clinical operations teams during active trials

Requirements

  • Strong statistics background with clinical trial data experience
  • Comfortable with both python and r for validation workflows
  • Familiarity with GCP (Good Clinical Practice) documentation standards
  • On-site presence required at our New York clinical operations office

Benefits

  • On-site role with dedicated clinical data lab
  • Health, dental, and vision insurance
  • 401k matching
  • Continuing education budget for clinical research certifications

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Job Type

Full-time

Level

Senior

Language

English

Salary Range

$130k – $160k / year

AI Expertise

Data Science & Analytics

Skills

python sql statistics pandas r

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