Clinical Data Specialist - Data Management
Current• Provide guidance and best practices into the design and implementation of databases that meet clinical data standards for CDISC. • Create study specific database Forms, Workflows, Data Validations, and Skip Logic based on study specified protocols in the Medrio eClinical Suite for clinical data capture. • Complete Utilization testing of each database created to ensure it meets all standards established in the protocol, and data transfer agreements submitted by the Study Sponsor. • As necessary query electronic data inconsistencies, and revise case report forms in compliance with standard operating procedures.• Development of data management plans for the Clinical Associate Director of Data Manager’s use on multiple studies. • Assist Clinical Associate Director of Data Manager with database design, and utilization based on consistent industry best practices, including GCP, which meet GDPR, and HIPPA Compliance. • Support all efforts to maintain regulatory compliance with collected data. • Provide administrative oversight including design, support, and reporting for a Salesforce CRM database of Leads and Contacts.• Create SMS forms, workflows, and UAT testing for remote study data capture in e-Research data system.