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Academic Quality Assurance Director
2 months ago
Job Summary:
Lstmed is seeking a highly skilled and experienced Academic Quality Assurance Manager to join our Clinical Sciences team. As a key member of our team, you will be responsible for ensuring the highest standards of quality and compliance in our clinical trial operations.
Key Responsibilities:
- Quality Management System (QMS) Leadership: Develop and implement a robust QMS that aligns with relevant regulatory guidelines, including ICH-GCP, country-specific regulations, Human Tissue Act, and Data Protection Regulation.
- Quality Assurance Leadership: Provide strategic guidance and oversight to ensure a culture of quality and compliance within the team.
- Clinical Research Support: Collaborate with researchers to plan and execute clinical research studies and trials, ensuring adherence to regulatory requirements.
- Training and Development: Design and deliver training programs to ensure high standards and regulatory compliance across all staff groups involved in clinical research.
- Quality Assurance Qualification: Possess a Quality Assurance qualification or equivalent relevant experience.
- Risk-Based Approach: Apply a risk-based approach to management and conduct of clinical trial activities.
Requirements:
- Enhanced DBS Check: The successful candidate will be required to undergo an enhanced DBS check prior to appointment and at regular points during employment.
About Lstmed:
Lstmed is a global health organization committed to promoting improved health, particularly for people in less developed and resource-poor countries in the tropics and sub-tropics. We actively promote Equal Opportunities and Safeguarding Policies.