Location: California
Job Summary:
Job Duties
- Provide quality oversight for global epidemiological studies within the Evidence Generation Platform.
- Coordinate vendor oversight, training, and quality review of study protocols.
- Ensure compliance with relevant regulations and internal SOPs.
- Develop inspection readiness tools and assist in audit preparation.
- Facilitate quality metrics and reporting, and address quality issues.
Required Skills
- Strong knowledge of ICH-GCP and research compliance.
- Effective collaboration and project management skills.
- Proficient in SOP evaluation, risk assessment, and audit management.
- Excellent interpersonal and communication abilities.
Required Experiences
- Bachelor’s degree with 10+ years or Master's degree with 8+ years in relevant research.
- Proven experience in clinical trials, non-interventional studies, and epidemiology.
- Familiarity with data privacy requirements and vendor management.
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