Clinical Data Specialist
Core
Execute technical setup of clinical programming and Electronic Data Capture (EDC) systems, ensuring data accuracy, integrity, and compliance with regulatory requirements for clinical trials.
Role type
Mid-senior IC clinical data specialist
Builds
Clinical databases and data sets for analysis and reporting
Domain
Pharma/Medtech clinical trials
Required skills
Clinical Data Management, EDC systems, Regulatory Compliance, Data Quality Assurance, Statistical Methods, Documentation & Reporting, Troubleshooting, Data Harmonization & Processing, Clinical Database Management Systems, Business Intelligence Tools
Preferred skills
Medidata Rave, Greenlight Guru, CCDM certification, Medidata database programming
Technologies
Medidata Rave, Greenlight Guru, Medidata database, Business Intelligence Tools
Responsibilities
Execute technical setup of clinical programming and EDC systems, Ensure adherence to data management standards and regulatory requirements, Develop and maintain documentation for data management processes, Support preparation and presentation of clinical data for analysis and reporting, Evaluate data quality and completeness to identify discrepancies, Collaborate with biostatistics teams on data analysis requirements
Seniority
Mid-senior, hands-on IC