Senior Clinical Quality Assurance Specialist
hace 22 horas
Job Overview
We are seeking a Senior Clinical Quality Assurance Specialist to join our team in Barcelona, Spain. This role will be responsible for driving the assessments of quality issues raised in Research and Development to ensure appropriate escalation, notification, categorization, mitigation, and health authority reporting.
Key Responsibilities
- Ensure consistency in incident management process and drive decisions on escalation, criticality, and categorization of quality issues.
- Be the key SME on QEM system/process and key point of contact for guidance on QI process and determination of issue criticality and categorization.
- Governance of all QIs to ensure consistent process and adherence to QIM procedure.
- Prepare pre-reads/presentation and meeting minutes with issue owner.
- Provide oversight of QEM records not in scope with periodic review of records to evaluate adherence to IMT principles.
- Lead and manage Health Authority reporting as needed to ensure reporting is completed in a compliant manner.
- Support audits and inspections as needed.
Requirements
- Minimum degree in Science, Engineering or relevant discipline.
- 8+ years industry experience specifically in clinical operations and clinical site management with a strong understanding of clinical research international standards and regulatory requirements from Health Authorities.
- Ability to work effectively in a matrix cross-functional environment and strong capacity for working independently with minimal guidance.
- Ability to make and communicate difficult decisions associated with strong written and verbal communication skills.
- English proficiency.
Salary and Benefits
The estimated salary for this position is around €80,000-€100,000 per year, depending on experience, plus benefits including company pension plan, life and accidental insurance, meals, allowance or canteen in the office, and flexible working hours.
About Us
Healthcare Businesswomen's Association is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We are an equal opportunities employer and welcome applications from all qualified candidates.
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