Responsible for ensuring clinical processes are conducted in accordance with guidelines and regulations. Develops, performs, and manages quality assurance activities. Presides over audits.
- Ensure that all processes contributing to the performance of a clinical trial are conducted properly.
- Troubleshoot clinical trials and activities.
- Manage and maintain databases for the quality system.
- Prepare and assist in preparing annual reports and quality trending reports.
- Report the status of the quality levels of staff, systems and production activities.
- Preside over improvement programs.
- Evaluate quality events, incidents, queries, and complaints.
- Keep up to date with all related quality legislation and compliance issues
- Compile and prepare materials for submission to regulatory agencies.
- Document internal regulatory processes.
- Ensure regulatory rules are communicated through corporate policies and procedures.
- Utilize guidance documents, international standards, or consensus standards and interpret for guidance.
- Ensure that investigator, vendor, facility and system audits are conducted.
- Communicate any critical compliance risks noted from these activities to senior management.
- Assume a lead role for the preparation, conduct, and responses to regulatory agency.
- Provide leadership and strategy in line with global strategic objectives.