Senior Clinical Quality Assurance Manager
4 weeks ago
Senior Clinical Quality Assurance Manager
About HR Genie:HR Genie is a dynamic and innovative company dedicated to delivering exceptional human resources solutions. We are seeking a highly skilled Senior Clinical Quality Assurance Manager to join our team.
Estimated Salary:$120,000 - $150,000 per annum
About the Role:Clinical Trial Quality OversightThe successful candidate will be responsible for ensuring the highest standards of quality in clinical trials and processes. This will involve implementing, managing, and improving the Quality Management System (QMS).
Key responsibilities will include ensuring adherence to Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements. The candidate will also oversee data quality and conduct quality control audits.
Compliance and Regulatory ManagementThe Senior Clinical Quality Assurance Manager will be responsible for monitoring and ensuring compliance with applicable regulatory standards. This will involve collaborating with regulatory bodies and maintaining proper documentation.
The candidate will also develop and implement strategies to mitigate risks and ensure compliance with quality standards.
Process Improvement and Risk ManagementThe successful candidate will identify risks and develop mitigation strategies to ensure business continuity. They will also lead process improvement initiatives and conduct root cause analysis to optimize business processes.
Training and DevelopmentThe Senior Clinical Quality Assurance Manager will be responsible for developing and delivering training programs to ensure team members are up-to-date on regulatory changes and quality standards.
Collaboration with Key StakeholdersThe candidate will work closely with clinical operations, data management, regulatory affairs, and project management teams to ensure seamless collaboration and communication.
Audit Preparation and ReportingThe Senior Clinical Quality Assurance Manager will prepare for and lead audits, compiling and presenting audit reports, quality metrics, and compliance findings.
Requirements:- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field
- Advanced degree or equivalent experience in clinical research or pharmaceutical quality management preferred
- Minimum of 5 years of experience in clinical research, with a focus on quality assurance or quality management
We are looking for a highly motivated and experienced professional who is passionate about delivering high-quality results. The ideal candidate will have a strong understanding of clinical trial processes, regulatory submissions, data management, and trial monitoring.
The successful candidate will possess excellent analytical and problem-solving skills, as well as the ability to lead and manage multiple projects.
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