
Senior Clinical Regulatory Compliance Specialist
21 hours ago
Job Overview: Senior Clinical Quality Assurance Manager
The role involves overseeing end-to-end clinical trial activities from a quality perspective, ensuring adherence to regulatory requirements and guidelines.
This position is responsible for developing and implementing a risk-based approach to quality compliance, safeguarding participants and data integrity.
Key Responsibilities:
- Establish SOPs for the QC function and review related SOPs for medical science, clinical teams, and data management
- Quality assess clinical trial medical science activities, including synopsis, protocol, CSR, and appendices
- Review clinical trial operations, tools, plans, and documentation for quality assurance
Essential Skills Include:
- Minimum 5+ years' experience in CRO/Pharma/Biotech organizations
- Strong attention to detail and conflict resolution skills
- Familiarity with GCP guidelines, ICMR regulations, and applicable laws
A successful track record, demonstrated through performance ratings and professional achievements, is highly desirable.
We offer a dynamic work environment that fosters growth and development. Our team is committed to excellence and innovation, driving success through collaboration and mutual respect.
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