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6 дней назад

Clinical Risk Manager I (RBQM)

Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
Slovakia
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Clinical Risk Manager I (RBQM): Developing and overseeing risk-based monitoring and integrated quality risk management strategies for complex and global clinical trials with an accent on critical data, protocol execution risks, and quality tolerance limits. Focus on creating risk management plans, enabling centralized data reviews, supporting cross-functional mitigation, and maintaining inspection readiness.

Location: Slovakia

Company

hirify.global supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, medical devices, and diagnostics.

What you will do

  • Develop monitoring strategies and complete study risk assessments for complex and global clinical trials.
  • Identify critical data, critical processes, protocol execution risks, and cross-functional mitigation strategies.
  • Evaluate and establish Quality Tolerance Limits and confirm that monitoring strategies are fit for purpose and risk proportionate.
  • Support Central Monitor activities by enabling aggregated data reviews through analytics and other methods.
  • Author Integrated Quality Risk Management Plans and configuration notes for Clinical Analytics programmers.
  • Support risk reviews, project planning, study kick-offs, inspection readiness, and RBQM knowledge sharing throughout the project lifecycle.

Requirements

  • Bachelor’s degree in Biological Sciences, Health Sciences, or a related healthcare discipline.
  • 8+ years of related experience in clinical research, RBQM, Central Monitoring, and Project Management.
  • Expertise in RBQM, Key Risk Indicators, Quality Tolerance Limits, Quality by Design, Centralized Monitoring, budgeting, and contracts.
  • Strong understanding of statistical concepts, statistical analysis techniques, and Integrated Quality Risk Management theories.
  • Experience with MS Excel, Business Intelligence tools, data visualization, and cross-functional global collaboration.
  • Excellent written and verbal English communication skills; ability to travel up to 20% for sponsor meetings.

Culture & Benefits

  • Opportunities to build skills and grow professionally.
  • Flexibility and balance to support personal needs.
  • Ability to influence ways of working and contribute ideas.
  • Work focused on medical innovation and improving patient outcomes.

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