What are the responsibilities and job description for the Senior Manager Clinical Quality Assurance position at SciPro?
Manager / Senior Manager Clinical Quality Assurance
Key Responsibilities
- Establishing robust GCP systems and processes in collaboration with the clinical operations team.
- Assist with Clinical Quality Assurance (CQA) efforts, including Trial Master File (TMF) and site auditing activities.
- Collaborate with clinical teams to ensure adherence to Good Clinical Practice (GCP) standards and internal protocols for clinical trials.
- Play a leadership role in assessing and contributing to clinical program planning and execution, including protocol reviews, informed consent forms (ICFs), corrective and preventive actions (CAPAs), and clinical study reports (CSRs).
- Provide quality oversight for clinical trial partners, such as Clinical Research Organizations (CROs) and contractors, while supporting the identification and onboarding of new third-party vendors as needed.
- Oversee the qualification and ongoing evaluation of GxP suppliers, ensuring significant findings are communicated to Quality Management and relevant stakeholders.
- Review clinical agreements to define roles, responsibilities, and communication protocols for quality-related tasks.
- Conduct internal and external audits, manage the investigation of findings, and oversee corrective / preventive actions, including root cause analysis and effectiveness checks.
Qualifications and Skills
