**Primary Function:**

**Centralized Monitoring Lead (CML)** partners with the Clinical Lead and local country Site Monitors in project execution. Provides centralized support to monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Monitors study start-up, manages resources, performs ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion. Leads team of Central Monitors(CM) and Clinical Analyst Support (CAS).

**Roles & Responsibilities: Study Start-up**

+ Maintains Clinical Operations Plan . Supports development of iSite Pack template, KDPMP and other tools/templates for DTE studies. Works with relevant stake holders for set-up and activation of DTE Alert/Triggers dashboard.
+ Ensure the SSV Attributes and Monitoring Attributes are updated appropriately on QRPM. Request site monitor resources for site selection visits. Verifies training compliance an...