Clinical Trial Associate für den Bereich Quality Assurance
(m/f/d)
Employment with Hays Professional Solutions GmbH Greater Frankfurt area Start date: asap Reference number: 821921/1
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Responsibilities
1. Quality Oversight & Systems Management: Monitor compliance with quality guidelines in clinical business areas and implement regional quality plans
2. Identify potential gaps, recommend solutions, and escalate relevant issues
3. Assist in maintaining and improving quality documents and processes
4. Audit & Inspection: Lead and support audit and inspection preparations, including document management and response coordination
5. Ensure trial sites and teams are inspection-ready
6. Consultation & Collaboration:Serve as the primary quality consultant, providing guidance on regulatory requirements and risk management
7. Support root cause analysis, CAPA processes, and audit planning
8. Collaborate with quality teams to strengthen quality culture and resolve issues
9. Process Improvement & Metrics: Drive continuous improvement and process optimization
10. Analyze quality metrics to identify gaps and recommend corrective actions to enhance compliance and efficiency
Profile
11. Education & Experience: Bachelor's degree in science, technology, or healthcare; experience in quality systems within clinical trials is required
12. Project Management: Strong ability to prioritize and effectively manage multiple tasks
13. Communication: Excellent communication skills and ability to influence various stakeholders
14. Analytical Skills: Problem-solving abilities and attention to detail for risk assessment and process optimization
15. Teamwork & Flexibility: Independent yet collaborative work style within global teams
16. Preferred: Experience in a global quality assurance environment and knowledge of regulatory requirements and clinical trial processes
17. German and Englisch fluent
Benefits
18. Vacation: 30 days
19. Work in an international Company