
Senior Clinical Quality Assurance Specialist
2 days ago
We are seeking a seasoned Clinical Quality Assurance (CQA) professional to play a key role in guiding study teams and ensuring quality oversight across ongoing clinical trials. This is a full-time contract role offering consistent work with flexible hours.
Key Responsibilities:- Provide QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, and study operations and trial oversight meetings.
- Write, review, update, and format standard operating procedures (SOPs) and other quality documentation.
- Manage and track quality processes within Veeva QMS, including document control, training, and CAPA management.
- Address QA-related questions from study teams in real time, providing clear and actionable guidance.
- Support inspection readiness and contribute to continuous improvement of QA systems and processes.
Requirements:
- Bachelor's degree in life sciences, healthcare, or related discipline (advanced degree preferred).
- 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP.
- Prior experience supporting clinical study teams in a QA capacity.
- Hands-on experience with Veeva QMS.
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