· Assists with Quality Control (QC) of specified deliverables
· Creates electronic Case Report Forms (eCRFs) according to finalized protocols for
EDC studies
· Creates data entry screens according to the approved annotated Case Report Form
(CRF) for paper studies
· Participates in database building design and testing according to Premier Research
standard operating procedures in operation at that time
· Assists in programming field derivations, edit/consistency checks, and setup of
screen flow in the CDMS for Data Entry
· Assists in writing procedures, validation and data extraction programs
· Produce database documentation including an annotated CRF.
· Ensure database documentation is maintained for the Trial Master File
· Works in collaboration with the Data Management project team, Statistician, Project
Manager and the sponsor to define all technical elements of the Data Management
plan
· May assist in maintaining the CDMS global and program libraries
· All other projects as assigned
Premier Research exists to help the world’s most innovative companies transform life-changing ideas and breakthrough science into new medical treatments to answer the unmet needs of patients everywhere. We succeed because we are Built for Biotech...
14 jobsSubscribe to Rise newsletter