CDC II
Core
Design and analyse clinical trials by managing clinical data, interpreting complex medical data, and ensuring data quality for innovative treatments.
Role type
Clinical Data Management Associate
Builds
Clinical trial data packages for pharmaceutical and biotechnology clients
Domain
Healthcare / Clinical Research / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical data management, data reconciliation, eCRF maintenance, data validation, 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
