Responsibilities 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). Receive and enter lab normal ranges. Qualifications 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. #J-18808-Ljbffr
Clinical Data Associate - Base
IQVIA
centurion, centurion
Published 14 days ago
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