
Quality and Compliance Assessor
2 weeks ago
Job Summary:
The Quality and Compliance Assessor collaborates with Clinical Research Associate (CRA) line management to perform quality oversight activities, ensuring consistent, high-quality performance in clinical trials. The role involves monitoring, auditing, analyzing oversight data, and providing guidance to improve operational quality across multiple projects and regions.
Key Responsibilities:
- Perform Routine and Non-Routine Monitoring Evaluation Visits (MEVs) and/or Sign-Off Visits (SOVs) as assigned.
- Analyze qualitative oversight data to identify quality improvement signals.
- Conduct root cause analysis of quality signals and develop action plans to implement process and efficiency improvements.
- Identify training needs for CRAs based on aggregated oversight data to meet quality and efficiency standards.
- Conduct training sessions in collaboration with Learning Center of Excellence, Corporate Quality, and Clinical Operations Management.
- Support Clinical Operations in resolving ad hoc or escalated quality concerns within the region.
- Act as a consultant to local/regional operations regarding quality oversight best practices and tools.
- Assist in reviewing Clinical Monitoring SOPs, tools, or templates related to monitoring oversight.
- Perform other work-related duties as assigned.
Qualifications:
- Bachelor's degree in biological science or healthcare-related field required.
- Minimum of 5 years of experience in monitoring or auditing clinical research programs at a CRO, biotech, or large pharmaceutical company.
- Additional experience as a CRA Line Manager, Project Manager, Clinical Team Manager, or Quality Control role preferred.
- In-depth knowledge of ICH/GCP, local regulations, drug development process, and clinical operations.
- Knowledge of multiple therapeutic areas.
- Ability to work independently within a matrixed environment across multiple projects and geographies.
- Strong attention to detail with excellent organizational, documentation, and presentation skills.
- Strong interpersonal and communication skills; ability to identify, analyze, and solve problems.
- Ability to perform root cause analysis.
- Willingness and ability to travel up to 75%, including internationally.
- Proficiency in written and spoken English; additional languages preferred in regional locations.
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