Sharing a Vision to Drive Healthcare Forward
Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources.
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Perform comprehensive data management tasks including data review, query generation and query resolution.This may also include, but is not limited to creation of eCRF completion guidelines, entry of test data for eCRF and the Data Review Model, testing of data validation rules, etc.Data Management tasks should be inclusive of Study Start-up, Execution, Database Lock and Close-out.
Perform ongoing Data Reconciliation of all data streams
Attend study related meetings/teleconferences
Perform Study Closeout/Archiving Activities including QC of subject/site Archival CRFs
Create and provide status/metric reports
Generate reports on EDC and track cleaning progress
Manage Freeze / lock of eCRF
File documentation in the virtual Trial Master File (TMF)
Receives and enters lab normal ranges
Education and Experience Guidelines:
Bachelor’s degree in a Health or Science discipline with experience in clinical research.
Data Management experience and experience working on a clinical trial mandatory.
Rave experience mandatory
Experience working in highly diverse teams within clinical research; cross-functional, global, multi- regional.
Knowledge of current industry standards (e.g., CDISC, SDTM, CDASH, etc.) for Advanced CDA.
Knowledge of technology platforms and systems to capture and process data
Project management skills.
Vendor management skills.
Proficiency with Microsoft Office tools
Experience CDA BASE level: 1-3 years of experience in Data Management at a CRO/Pharma