6 дней назад
Clinical Risk Manager I (Clinical Research)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Risk Manager I (Clinical Research): Developing risk-based monitoring strategies and integrated quality risk management plans for complex clinical trials with an accent on critical data, critical processes, and protocol execution risks. Focus on evaluating quality tolerance limits, enabling centralized data reviews, and maintaining inspection readiness across the study life cycle.
Location: Romania
Company
supports biotech, medtech, and specialty pharmaceutical companies in developing medicines, medical devices, and diagnostics.
What you will do
- Develop monitoring strategies based on initial clinical trial risk assessments and support proposals and business development.
- Complete risk assessment and categorization activities for complex and global trials, identifying critical data, critical processes, and protocol execution risks.
- Evaluate and establish Quality Tolerance Limits and confirm that monitoring strategies are fit for purpose and risk proportionate.
- Support centralized monitoring through analytics tools, configuration notes, and aggregated data reviews.
- Author Integrated Quality Risk Management Plans and support cross-functional protocol execution risk reviews throughout the project life cycle.
- Maintain inspection readiness documentation, support kick-off meetings, and share RBQM knowledge across the team.
Requirements
- Bachelor’s degree in Biological Sciences, Health Sciences, or a related healthcare discipline.
- 8+ years of clinical research experience related to risk-based quality management, centralized monitoring, and project management.
- Subject matter 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 leading process improvement initiatives and collaborating with global cross-functional teams to solve complex problems.
- Excellent written and verbal English communication skills; ability to travel up to 20% for sponsor meetings.
Culture & Benefits
- Flexible work practices designed to support professional growth and work-life balance.
- Opportunities to develop RBQM expertise and share knowledge within the team.
- Work contributing to the development of medicines, devices, and diagnostics that improve patients’ lives.
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