development and knowledge-sharing. Expertise in industry-standard EDC systems and familiarity with CDISC/CDASH standards...
collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines... and scripts;EDC build and associated edit checks Provide study level metrics/reports and external data reconciliation processes...
with Principals and Managers on EDC platform optimization, clinical data management process improvement, CDISC standards.... Key Focus Areas Clinical Data Management & CDISC Compliance: SDTM, ADaM, Define.xml, CDASH (with SEND awareness). EDC...
source documentation, data collection (i.e. development, completion and submission of case report forms (EDC), study drug...
experience implementing Informatica Cloud Data Quality (CDQ) and Cloud Data Catalog (EDC/CDGC), working closely with data... Informatica Cloud Data Catalog (EDC/CDGC) Onboard application and data source metadata in collaboration with application owners...
and regulatory requirements Experience with clinical databases, electronic data capture (EDC) systems, wearables, and sensors...
from the ground up. Oversee implementation and validation of EDC systems, LIMS, and data warehouse tools to harmonize internal... data. Familiarity with EDC systems (Medidata, REDCap, etc.), data visualization tools (Tableau, Spotfire, Power BI...
Responsibilities Collect, enter, and manage clinical trial data using electronic data capture (EDC) systems... data management or a related clinical research role. Familiarity with EDC systems (e.g., Medidata Rave, Oracle Clinical...
with EDC/TDC/CaC semantics and their impact on power. A validated SoC power model & scorecard that anchors program power... correlation plans (CaC/static/dynamic splits, EDC/TDC interactions, droop mitigation) and maintain a power scorecard for program...
and checks, and drive reconciliation (e.g., IRT IDs, visit alignment, drug allocation events vs. EDC). Partner with Data.../validation, data privacy, and GxP expectations. Demonstrated capability in data integration and reconciliation (IRT ↔ EDC/CTMS...