Clinical Trials Project Manager

Posted 1hrs ago

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Job Description

Clinical Trials Project Manager coordinating central-laboratory clinical studies for Rochester Regional Health. Managing protocols, regulatory documentation, client communication, budgets, training, and study closeout.

Responsibilities:

  • Liaise with ACM Global Central Laboratory clients as the laboratory representative for clinical trials
  • Liaise internally with all groups to ensure trials follow the Global Laboratory Specification Document
  • Manage assigned clinical trials from setup through maintenance and study closeout
  • Serve as the client's primary point of contact and maintain customer satisfaction
  • After training, manage 10 to 25 protocols depending on scope and complexity
  • Review clinical protocols and assist with protocol setup
  • Develop Global Laboratory Specification Documents, Investigator Manuals, and protocol-specific Global Work Practice Instructions
  • Participate in and document clinical trial quality audits and inspections
  • Evaluate and communicate monthly project metrics and analyze trial activity, including monthly budget review
  • Conduct investigator training sessions by telephone or at investigator meetings
  • Travel to client events and ACM international locations as required
  • Ensure client goals and timelines are met; troubleshoot and solve problems
  • Provide assigned on-call coverage
  • Maintain regulatory-required study documentation and archive materials according to regulations, ACM policies, and client contractual clauses
  • Develop protocol-specific procedures as needed
  • Follow company policies and procedures while maintaining patient and client confidentiality

Requirements:

  • 1+ years project management experience
  • Bachelor's Degree is preferred
  • Experience working in a clinical trial, laboratory or healthcare setting is preferred
  • General working knowledge of FDA, NYSDOH, GCP, ICH and other pertinent regulations as they pertain to central laboratory functions
  • Ability to travel overnight, frequently on weekend days
  • Ability to travel to client events and ACM international locations
  • Passport qualifications
  • Ability to take assigned on-call coverage duties
  • Ability to maintain patient and client confidentiality
  • Ability to perform sedentary, primarily office-based work with prolonged sitting and minimal physical effort
  • Excellent problem solving and communication skills are preferred

Benefits:

  • Overnight travel and travel to client events and ACM international locations
  • Additional pay components may be available
  • Potential flexible hours
  • Reasonable accommodations for reported physical requirements