
Clinical Trial Regulatory Affairs Specialist
1 week ago
Role Overview:
We are seeking a seasoned Clinical Quality Assurance Compliance Specialist to join our team. This role will be responsible for overseeing end-to-end clinical trial activities from a quality perspective, ensuring adherence to applicable regulations and guidelines.
Key Responsibilities:
- Review of study related activities, processes, procedures to ensure 24x7 Inspection/audit readiness
- Establishment of procedures and trainings to ensure protection of human subjects, reliability/integrity of data
- Development and implementation of risk-based and flexible approach to Quality Compliance (QC)
- Preparation and review of SOPs related to QC function
- Quality review of clinical trial medical science related activities
Requirements & Qualifications:
- 5 years' experience in Quality department with experience of Quality activities in Clinical Research department
- Strong eye for detail, ability to spot inconsistencies, good conflict management skills
- Experience in handling audits & inspections, thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations
- Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards
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