Clinical QA/ QC Manager - (Pennington, NJ)

The Clinical QA/ QC Manager will be responsible for ensuring clinical processes are conducted in accordance with guidelines and regulations. Develops, performs, and manages quality assurance activities. Key responsibilities: 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 " training, SOPs implementation 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.