• Performs Lead CDM role for assigned studies • Designs and/or assists with design of the clinical database based on protocol and study needs, including queries and dynamics • Performs User Acceptance Testing (UAT) of the clinical database • Authors, reviews, and approves study specific CDM documentation (DMPs, CCGs, DTAs, EDC specifications) • Performs data cleaning activities for assigned studies; provide oversight of data cleaning activities for outsources studies • Monitors study progress to ensure successful achievement of study milestones • Provides oversight of CDM vendors for assigned studies • Ensures that all CDM operations are conducted according to applicable SOPs • Identifies and communicates potential risks/challenges to head of CDM and study CPM based on protocol, timelines, forecasts, and study metrics. • Collaborates with the study team to identify, develop, and implement risk-based solutions • Ensures CDM study documents are filed in the TMF (Trial Master File) in a timely manner • May oversee tasks delegated to other CDM staff for assigned studies • Performs other duties as required