
Clinical Quality Assurance Compliance Specialist
1 day ago
Job Title: Clinical Quality Assurance Compliance Specialist
Overview:
We are seeking a skilled Clinical Quality Assurance Compliance Specialist to oversee end-to-end clinical trial activities from a quality perspective.
Responsibilities:
- Oversight of quality compliance (QC) activities across various teams, including Medical Science, Operations, and Data Management.
- Review of all study-related activities, processes, procedures, and adherence to applicable regulations and guidelines to ensure inspection/audit readiness.
- Establishment of procedures and training for teams to protect human subjects from research risk, ensure data reliability/integrity, and maintain internal consistency and QC measures.
- Development and implementation of a risk-based and flexible approach to QC within the function.
Requirements:
- 5+ years of experience in a CRO/Pharma/Biotech organization with expertise in Quality activities in Clinical Research departments.
- Strong attention to detail and conflict management skills.
- Familiarity with recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations.
- Experience working in matrix business environments preferred.
Preferred Skills:
.
Additional Information:
This role requires a strong understanding of regulatory requirements and industry best practices. The ideal candidate will have excellent communication and interpersonal skills, as well as the ability to work effectively in a team environment.
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