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Clinical Compliance Auditor
Danaher Corporation. Support and coordinate internal and external audits .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical compliance auditing, including conducting audits, developing clinical processes, and maintaining quality metrics. Proficient in supporting clinical study teams and ensuring adherence to applicable standards and regulations.
Highest-signal resume keywords
Clinical Compliance AuditingNMPA InspectionsVendor/Supplier QualificationClinical Process DevelopmentAudit Findings Tracking
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Standards KnowledgeAudit Schedule DevelopmentCorrective Action DocumentationClinical Metrics MaintenanceSOP Development
Soft Skills
CollaborationProblem-SolvingTraining Support
Industry Keywords
Clinical AuditsCompliance StandardsRisk AssessmentsClinical Study Support
About the role
Key responsibilities & impact- Support and coordinate internal and external audits
- Support development of an annual audit program and schedule
- Lead or support site and sponsor clinical audits
- Assess and audit clinical study compliance with applicable standards and regulations
- Write and distribute audit schedules, plans, and reports
- Assess objective evidence and rank nonconformance findings
- Track audit findings and corrective actions and document their completion
- Develop and maintain clinical and quality metrics
- Participate in NMPA inspections
- Manage and conduct the full lifecycle of vendor and supplier qualification
- Develop compliant clinical processes
- Maintain and update processes, procedures, and SOPs
- Support training Clinical Affairs staff on regulations, standards, requirements, processes, best practices, and SOPs
- Support clinical study teams and troubleshoot clinical compliance issues
- Collaborate with customers and global teams to help solve complex challenges and bring science and technology to life
Requirements
What you’ll need- Experience or qualifications in clinical compliance auditing are not explicitly stated
- Knowledge of applicable clinical standards and regulations
- Knowledge of NMPA inspections
- Ability to conduct site, sponsor, vendor, and supplier audits
- Ability to perform vendor/supplier qualification and risk assessments
- Ability to develop and maintain clinical processes, metrics, procedures, and SOPs
- Ability to support clinical study teams and troubleshoot clinical compliance issues