
Clinical Quality Assurance Compliance Specialist
1 day ago
Clinical Quality Assurance Compliance Manager
">Job Title: Clinical Quality Assurance Compliance and Training Specialist
Experience: 5+ years
Location: Mumbai
Type: Full-time
Experience Level: [Senior] Manager/Senior Manager
Department: Clinical Research Department
Purpose of this Role:
This role will be responsible for end-to-end oversight of clinical trial activities from a quality perspective. The role will ensure compliance with applicable regulations and guidelines, guaranteeing 24x7 inspection/audit readiness.
The successful candidate will establish procedures and training programs to safeguard human subjects from research risks and ensure data integrity and internal consistency.
Key Responsibilities:
• Develop and implement risk-based quality compliance within the function
• Identify team member's job-specific SOP training requirements
• Prepare SOPs related to QC function and review SOPs specific to Medical Science, Clinical Team, and Data Management Team
• Conduct quality reviews of clinical trial medical science-related activities
• Review clinical trial operation-related activities and documentation
Required Skills and Qualifications:
• Minimum 5 years' experience in Quality department with experience of Quality activities in Clinical Research Department
• Strong eye for detail and ability to spot inconsistencies
• Good conflict management skills
• Experience in handling audits & inspections of DCGI, US FDA
• 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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