Clinical Risk Manager I (Medtech)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Clinical Risk Manager I (Medtech): Managing clinical risk and quality strategies for global trials with an accent on Risk-Based Quality Management (RBQM) and protocol execution. Focus on establishing Quality Tolerance Limits (QTLs), authoring Integrated Quality Risk Management Plans (IQRMP), and ensuring inspection readiness through cross-functional collaboration.
Location: Must be based in Spain
Company
is a global clinical research organization helping biotech, medtech, and pharma companies transform breakthrough science into life-changing medical innovations.
What you will do
- Develop and implement overarching monitoring strategies and risk assessments for clinical trials.
- Complete study Risk Assessment and Categorization Tools (RACT) and establish Quality Tolerance Limits (QTLs).
- Author and maintain Integrated Quality Risk Management Plans (IQRMP) throughout the project lifecycle.
- Serve as a Subject Matter Expert (SME) on Risk-Based Monitoring (RBM) and RBQM activities.
- Ensure inspection readiness by maintaining accurate documentation and supporting cross-functional risk reviews.
- Collaborate with clinical analytics teams to configure tools for aggregated data reviews.
Requirements
- Must be based in Spain
- Bachelor’s degree in Biological Sciences, Health Sciences, or related disciplines.
- 8+ years of clinical research experience with a focus on RBQM, Central Monitoring, and Project Management.
- Subject matter expertise in ICH-GCP, ICH E6 (R2/R3) guidelines, KRI, QTLs, and Quality by Design (QbD).
- Strong analytical skills with expertise in MS Excel and Business Intelligence tools.
- Excellent verbal and written communication skills in English (C1 level).
- Ability to travel up to 20% for sponsor meetings.
Culture & Benefits
- Opportunity to work on life-changing medical innovations and breakthrough science.
- Commitment to professional growth and skill development.
- Flexible work environment focused on work-life balance.
- Collaborative, global team culture where individual contributions are valued.
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