Hard Skills
AdvancedClinical Data Management (CDM)The systematic process of collecting, cleaning, and managing subject data in compliance with regulatory standards for clinical trials.
IntermediateElectronic Data Capture (EDC) Systems ProficiencyTechnical expertise in utilizing software platforms such as Medidata Rave or Oracle Clinical to capture and manage clinical trial data.
AdvancedGood Clinical Practice (GCP) ComplianceAdherence to international ethical and scientific quality standards for designing, conducting, and recording clinical trials.
IntermediateMedical Coding (MedDRA/WHODrug)The process of assigning standardized codes to medical terms, adverse events, and medications for global analysis.
IntermediateQuery Management and Data CleaningThe identification, tracking, and resolution of data discrepancies found during the clinical data review process.
Soft Skills
AdvancedAnalytical ThinkingThe ability to scrutinize complex datasets to identify trends, outliers, and potential systemic issues in data collection.
IntermediateInterdisciplinary CommunicationThe ability to translate complex technical data requirements to clinical monitors, investigators, and biostatisticians.