Senior Clinical Quality Assurance Specialist
2 days ago
Job Title: Clinical Quality Assurance Compliance Expert
Role Summary:
This is a senior leadership position responsible for overseeing end-to-end clinical trial activities from a quality perspective. The role requires strong attention to detail, effective conflict management skills, and thorough knowledge of recent GCP guidelines, ICMR regulations, and applicable regulatory requirements.
Key Responsibilities:
- Ensure quality compliance with relevant regulations and guidelines across all clinical trial-related activities.
- Develop and implement risk-based approaches to quality compliance, ensuring the protection of human subjects and integrity of data.
- Establish procedures and trainings to ensure internal consistency and adherence to regulatory requirements.
- Prepare and review SOPs related to quality functions, medical science, clinical teams, and data management teams.
Requirements and Qualifications:
- 5+ years of experience in a CRO/Pharma/Biotech organization with a background in quality assurance and control.
- Strong analytical and problem-solving skills, with the ability to identify inconsistencies and resolve conflicts effectively.
- Excellent communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
- Thorough knowledge of GCP guidelines, ICMR regulations, and applicable regulatory requirements.
Preferred Skills:
- Experience working in matrix business environments.
- Strong track record of success, demonstrated through annual performance ratings and/or professional accomplishments.
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