CDC II
Core
Design and analyze clinical trials by managing clinical data, interpreting complex medical data, and ensuring data quality for pharmaceutical/biotech sponsors.
Role type
Intermediate clinical data manager (CDM)
Builds
Clinical trial data packages for pharmaceutical and biotechnology sponsors
Domain
Clinical research / Pharmaceutical data management
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical data management, eCRF maintenance, data validation, data reconciliation, root cause analysis, regulatory guidelines knowledge (ICH-GCP), data management software proficiency
Preferred skills
Knowledge of regulatory guidelines and standards (e.g., ICH-GCP)
Technologies
Medidata, Oracle RDC
Responsibilities
Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures; Manage clinical and third-party data reconciliation based on edit specifications and data review plans; Track and communicate status of study and task metrics to clinical data scientist, project team, and functional management; Address data related questions and recommend potential solutions; Identify root cause to systematically resolve data issues
Seniority
Intermediate, hands-on IC