Clinical Quality Assurance Specialist
1 day ago
The ideal candidate will provide day-to-day clinical quality assurance support across ongoing clinical trials, ensuring compliance with Good Clinical Practice (GCP) and internal quality standards.
- Provides QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, and study operations and trial oversight meetings.
- Serves as the primary QA support resource for clinical study teams.
- Ensures compliance with GCP and internal quality standards.
- Provides clear and actionable guidance to study teams.
This role requires strong experience with Veeva QMS, excellent communication and interpersonal skills, and a high level of technical aptitude.
Qualifications:
- Bachelor's degree in life sciences, healthcare, or related discipline.
- 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.
- Technical Skills:
- Proficient in MS Office (Excel, PowerPoint, Word).
- Skilled in technical writing, SOP drafting, and document formatting.
- Soft Skills:
- Excellent communication and interpersonal skills.
- Strong organizational skills with the ability to work independently.
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