Rochester Regional Health

Clinical Trials Project Manager

Rochester Regional Health

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $80,000 - $105,000 per year

Job Level

Junior

Tech Stack

Google Cloud Platform

About the role

  • Liaise with ACM Global Central Laboratory clients, representing the laboratory aspects of conducting the clinical trial.
  • After training, manage from 10 to 25 protocols, with contract value over $3,000,000 and >120 PM billable hours/month.
  • Review clinical protocols and assist with protocol set-up functions as required.
  • Develops Global Laboratory Specification Document, Investigator Manual, and protocol-specific Global Work Practice Instructions.
  • Participate in quality audits and inspections per regulatory agencies.
  • Evaluate and communicate monthly project metrics, including budget review.
  • Conduct investigator training sessions by telephone or at investigator meetings, which involves overnight travel, frequently on weekend days.
  • Travel to client events and ACM international locations as needed, requiring overnight travel.
  • Assume responsibility for study conduct and on-call duties; ensure client’s goals and timelines.
  • Maintain regulatory required study documentation and comply with standard procedures for collecting, maintaining and archiving materials.
  • Develops protocol specific procedures as needed; knowledge of FDA, NYSDOH, GCP, ICH.

Requirements

  • 1+ years project management experience
  • Bachelor’s Degree
  • Experience working in a clinical trial, laboratory or healthcare setting
  • Excellent problem solving and communication skills