Key Responsibilities: • Ensures all site related activities and files are completed per the SOPs. • A key point of contact for study specific questions from both internal (e.g., site monitors, clinical services specialist) and external (e.g., site personnel, vendors) customers. • Facilitate communication across departments and elevate site and study issues as appropriate.• Reviews clinical data through monitoring reports and data listings in order to monitor overall clinical data quality and identify and resolve potential study or site issues as appropriate. • Perform quality checks of all study plans (e.g., monitoring plan) and study reports. • Review and code protocol deviations.• Sets-up, tests, reviews, and updates clinical systems (e.g., CTMS) and tracking tools. • Responsible for collecting and tracking study specific data and producing clinical status, trend, and metric reports to assist the manager in proactive study management and contingency planning.• Responsible for the logistical tasks associated with the preparation, collection, review and tracking of the master and site non regulatory file documents. • Ensure the accuracy and completeness of all study files prior to final archival.• Responsible for reporting any potential GCP violations either internally or externally to their manager and participate in any corrective and preventative action plans as appropriate. • Reporting any safety concerns to the appropriate department • Responsible for adherence to all relevant regulations including ICH, PhRMA and CFR guidelines, as well as Allergan's policies, SOPs and Work Instructions. Ongoing training in compliance