What are the responsibilities and job description for the Director of Clinical Quality Assurance position at SciPro?
Associate Director / Director of Clinical QA
6 Month Contract - Extension and Conversion Potential
Responsibilities :
- Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.
- Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.
- Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.
- Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, root cause analysis, CAPA planning and management.
- Escalate identified issues to QA Management as needed.
- Enable other assigned GCP or GXP related tasks, as appropriate.
Required Skills, Experience and Education :
