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Compliance Director
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- The Compliance Director is responsible for leading the company’s Compliance Team, including oversight of regulatory affairs, source development, data management, quality assurance, and compliance.
- The Compliance Director is responsible for ensuring that the company’s data collection meets ALCOC standards and that all clinical research activities are conducted in accordance with ICH GCP guidelines, FDA regulations and guidance documents, Charter Research SOPs and work instructions, and applicable federal and state regulations and guidelines.
- Develop, implement, and maintain quality assurance standards and practices, ensuring adherence to protocols, data integrity, and patient safety in all clinical research activities.
- Plan and lead the execution of day-to-day activities for quality control checks, data collection, regulatory requirements, deviation and SAE tracking, and CAPA tracking and follow-up.
- Ability to lead, speak, and be a champion for data integrity, quality, and regulatory excellence.
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