Senior Data Manager
* Proficient in OC/RDC - Oracle Clinical remote data capture.
* Developing, coordinating, and monitoring the data management process across the assigned team.
* Managing clinical trial data through review, computerization, cleaning, and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines, good clinical practices, and regulatory agency guidelines
* Maintaining and developing client communication with regards to data management project status, issues that arise, and completion of tasks within the project
* Developing, testing and maintaining computer edit checks
* Development of case report forms (CRFs)
* SAE reconciliation
* Lab data reconciliation
* Completely 21 CFR Part 11-compliant division; strict adherence to HIPAA is required; GCP observed & maintained.