Principal, Data Manager

The Principal Data Manager leads and drives the DM team, acting as a mentor and coach, and serves as the reference point for the Sponsor and the appointed project representative from a Data Management perspective. They are accountable for driving the achievement of project milestones from study start-up through to database delivery. Responsibilities include providing Data Management input into protocols, designing Case Record Forms (CRFs) and guiding the CRF approval process, and defining and developing the Data Management Plan, Data Validation Plan, and their annexes. They are responsible for database validation and computerized checks, defining User Acceptance Test Plans for EDC studies, and ensuring timely responses to issues identified by the eCRF Helpdesk. The role involves preparing CRF completion guidelines, study-specific data-entry guidelines, and training data-entry staff. Performing term coding, managing queries, and overseeing the data cleaning process are key duties. Additionally, they create and test import programs for electronic data, perform timely data integration, and reconcile external data. They run and monitor study data progress reports, escalate study issues, define and execute QC plans, and lead database release and freeze activities. The Principal Data Manager coordinates other DM staff, provides direction on work assignments, scheduling, and prioritization, and inputs into and monitors progress against study project plans. They educate and train on data collection tools and query management processes, and maintain continuous communication with sponsors, sharing critical and general issues.