Elizabeth Cristina
Senior Clinical Data Manager @Pulmovant
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WORK HISTORY
Senior Clinical Data Manager @Pulmovant
EDUCATION
Harvard University
Ethnobotany
University of Michigan Biological Station
Limnology, Botany, Boreal Flora
University of Colorado, Boulder
B.S., Biochemistry and Molecular Biology
SKILLS
ABOUT ELIZABETH CRISTINA
Over 25 years of hands on clinical trial and data management experience. Senior Management roles, Clinical Data Management oversight. Serve as the lead program data manager on development projects working in Rave/Veeva/Oracle, collaboration with external vendors with responsibility for managing the design, implementation, and maintenance of electronic case report forms, and electronic edit checks for new and ongoing clinical research studies. Additional responsibilities include the design, development, implementation, and execution of data review plans to ensure the quality of collected clinical data, including oversight of multi-functional data review teams, management of electronic data received from specialty vendors (e.g, clinical laboratory, central image review), and the development of technical study documents and reports such as data transfer plans, annotated case report forms and database/data quality metrics. eTMF file structure development based on the standard DIA eTMF Reference Model guidelines using Veeva Vault and SharePoint file systems. Part of CRO selection team, RFP process, budgeting/bidding DM portions of overall study proposals.
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