
Senior Clinical Quality Assurance Professional
20 hours ago
This is a senior-level role within our organization responsible for ensuring the highest standards of quality assurance in clinical trial activities.
- Key Responsibilities:
- Develop and implement a risk-based approach to quality compliance, safeguarding trial participants and data in line with regulatory requirements and best practices.
- Establish procedures and trainings to ensure protection of human subjects from research risk, reliability/integrity of data, and internal consistency.
- Identify team member job-specific SOP training requirements and maintain oversight of training to ensure all team members are trained as required.
Requirements:
- 5 years' experience in a CRO/Pharma/Biotech organization in quality department with experience of quality activities in clinical research department.
- Strong analytical skills, ability to spot inconsistencies, and good conflict management skills.
- Experience in handling audits & inspections, thorough knowledge of recent GCP guidelines, ICMR guidelines, and other applicable regulations pertaining to clinical trials.
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