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Quality Risk Manager

1 month ago
United States
Full-time
Mid Level
QA Engineer
Quality Assurance and Testing
Apply Now
Rho

Rho

Rho is a full-service Contract Research Organization (CRO) that combines innovation and scientific rigor to maximize results in every phase of clinical research. With a global team of experts, Rho ensures consistent and efficient trials, offering compr...

Biotechnology
251-1K
Founded 1984
View All Jobs 15

Description

  • Manage project-level RBQM activities and documentation across multiple studies.
  • Lead study-specific risk assessments and recommend anticipated risks and mitigations.
  • Develop and maintain the Integrated Quality Risk Management Plan (IQRMP) and Quality Risk Log for assigned studies.
  • Review study and site data listings and dashboards to identify trends, risks, misconduct, or systematic errors affecting data integrity and subject safety.
  • Escalate serious issues promptly and help develop action plans with the project team.
  • Set up and support Key Risk Indicator (KRI) visualizations using a technology platform or alternate tool.
  • Support strategic quality review meetings and ongoing RBQM process and tool optimization activities.
  • Coordinate cross-functional study team activities and help ensure project objectives, deliverables, and timelines are met.
  • Support audits and audit readiness efforts for internal and sponsor reviews.
  • Identify process improvement opportunities and communicate them to RBQM leadership.

Requirements

  • Bachelor’s degree in science or a related field.
  • 3 years of industry experience.
  • Experience in a clinical research setting in clinical monitoring, data management, biostatistics, or a related function, and/or at least 1 year of strong performance in an AQRM role.
  • Sound knowledge of Good Clinical Practice and ICH E6 (R3) guidelines, risk-based monitoring strategies, processes, and tools.
  • Basic knowledge of clinical data collection, monitoring, and review processes.
  • Strong understanding of the clinical data lifecycle from protocol creation through database lock and analysis.
  • Ability to adapt quickly to changing priorities and manage multiple projects within moderate oversight.
  • Strong computer skills, including advanced MS Excel functionality such as sorting, filtering, calculations, and pivot tables.
  • Proficiency with analytical data visualization tools.
  • Strong critical thinking, problem-solving, and sound judgment skills.
  • Clear and professional written and verbal communication skills with internal and external stakeholders.
  • Ability to maintain confidentiality.
  • Expected travel of 15% on average.

Benefits

  • Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life insurance, disability insurance, and 401(k).
  • Paid time off.
  • Paid holidays.
  • Parental leave.
  • Bereavement leave.
  • Flexible work-life balance culture.
  • Starting salary range of $80,000 to $108,000 per year, depending on level.

Interested in this position?

Apply directly on the company website

Apply Now

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