
Clinical Assurance Specialist
2 weeks ago
Job Overview:
We are seeking a seasoned Clinical Quality Assurance Compliance expert to oversee clinical trial activities from a quality perspective. This role will be accountable for ensuring compliance with regulatory requirements, industry standards, and best practices.
Main Responsibilities:- Develop and implement risk-based quality compliance strategies within the function
- Identify and determine team member's job-specific SOP training needs
- Prepare and review SOPs related to QC functions
- Conduct quality reviews of clinical trial medical science and operations-related activities
- Maintain oversight of training to ensure all team members are trained on each SOP as required
- 5 years' experience in a CRO/Pharma/Biotech organization in a Quality department with experience of Quality activities in Clinical Research departments
- Strong attention to detail and ability to identify inconsistencies
- Good conflict management skills
- Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations pertaining to clinical trials
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