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Clinical Compliance Director
1 month ago
Oversee a comprehensive compliance program for Hologic Diagnostic Solutions Clinical Affairs, ensuring adherence to regulatory standards and industry best practices. Develop and implement strategic frameworks for clinical compliance, fostering a culture of integrity and driving risk management through proactive compliance programs.
Key Responsibilities- Develop and manage the Clinical Quality Management System to ensure compliance with applicable laws, regulations, and guidelines.
- Lead the development, approval, and periodic review of controlled documents related to clinical study processes and systems.
- Maintain expert knowledge of current and proposed clinical research-related laws, regulations, guidelines, and initiatives.
- Participate in industry and regulatory working groups to collect and disseminate clinical regulatory intelligence.
- Collaborate with senior leaders in Clinical Affairs to establish strategic plans and objectives for efficient clinical execution.
- Ensure audits of clinical trial master files, clinical trial sites, clinical suppliers, and clinical department systems are conducted and reported on a periodic or as-needed basis.
- Minimum 8 years of experience in audit, compliance, risk, assurance, and governance, ideally with international and team leadership experience in clinical research.
- Strong knowledge of relevant international clinical compliance policies and regulations, and solid understanding of the diagnostics and healthcare industry.
- Inter-cultural understanding and experience in change and project management.
