Lead Data Manager responsible for data management in clinical trials for a global organization. Overseeing complex studies and team communication within clinical data management.
Responsibilities
Responsible for all data management activities in large, complex studies
Primary communication point for project teams and company departments regarding clinical data management
Co-ordinate/perform user acceptance testing
Development of Data Validation Plan/Edit Check Specifications
Data validation and query generation
Coordination of processing, dispatch and archiving of CRFs/queries
Preparation and attendance at audits/inspections of Data Management
Training of Assistant Data Managers and clinical team regarding CRF completion
Requirements
College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
At least 3 years of experience of full scope of data management responsibilities in global EDC studies
At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
Data Manager supervising clinical data management activities for clinical trials. Acting as communication line for project teams and managing documentation tasks.
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