Deadline for applications: Thursday, July 13, 2023, 11:59 PM (ET)

Your talent is needed to lead quality risk management in the realm of world-leading health research! Come join the Population Health Research Institute (PHRI) to make a meaningful difference. (This role is eligible for hybrid/remote work.)

As our Quality Risk Management Coordinator, you will…

  • Provide leadership as the subject matter expert in area of Quality by Design (QbD) and Quality Risk Management (QRM) for clinical research studies
  • Uphold a high level of understanding of regulatory agencies and other external and internal stakeholders’ requirements in terms of data quality
  • Coordinate the work of data management/statistical reporting to define metrics and tolerance limits for each identified risk
  • Lead the QRM process for clinical research studies, leading study teams in the identification and assessment of study risk, using QbD principles and CtQ factors
  • Establish study specific QRM Plans, based on the Risk assessments, including tolerance or threshold limits and corresponding mitigation strategies
  • Engage with study teams in determining defect rates, quality tolerance limits and risk management strategies
  • Integrate a continuous quality improvement framework into QRM practices and implementing QRM process improvements
  • Contribute to the development of QRM methodology and best practices
  • Other duties as outlined by the manager of PHRI’s QA department

Qualifications include:

Required: Undergraduate degree in science or health related or equivalent; ICH GCP and national regulatory agency certificates (ICH-GCP, FDA, Health Canada, and EMA); 3+ years’ experience in pharmaceutical and/or medical device clinical research; 2+ years’ experience in clinical data monitoring and quality risk management.

Highly recommended: Formal clinical research certification (i.e. SOCRA, ACRP).

This is a Hamilton Health Sciences full-time, regular posting: 37.5 hours/week Monday through Friday, based in Hamilton, Ontario; eligible for hybrid remote work.

More information (including pay range) and to apply, go to: Job Number 105130

Deadline for applications: Thursday, July 13, 2023, 11:59 PM (ET)

Operational Excellence Supporting World-Leading Research – Join PHRI!

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