Clinical Data Manager
Core
Ensure accuracy, quality, security, and reliability of clinical research data across pre-market and post-market studies for medical devices.
Role type
Senior Clinical Data Manager
Builds
Clinical study databases and Case Report Forms (CRFs) for regulatory submissions and statistical analysis
Domain
Medical devices / Clinical Research
Required skills
Clinical data management (CDM), Case Report Form (CRF) design, database development and validation, User Acceptance Testing (UAT), Data Management Plans (DMP), discrepancy management, regulatory compliance (GCP, ICH, FDA, EU), stakeholder collaboration
Preferred skills
Clinical Research Associate (CRA) experience, pre-market clinical study experience, data analysis
Technologies
Clinical data management software, Microsoft Office (Word, PowerPoint)
Responsibilities
Develop and manage CRFs for clinical studies; coordinate with database vendors for development and testing; perform UAT for database builds; draft and maintain Data Management Plans; oversee data quality and discrepancy management; collaborate with Data Science on statistical analyses; coordinate database locks for regulatory submissions; support internal and external audits
Seniority
Senior, hands-on IC