Senior Pharmaceutical Data Manager
Core
Ensuring accuracy, integrity, and timeliness of clinical trial data collected during drug development through database design, validation, and compliance management.
Role type
Senior pharmaceutical data manager
Builds
Clinical trial databases and validated datasets for drug development
Domain
Pharmaceutical industry + Clinical data management
Required skills
Clinical database design, data validation, EDC systems, regulatory compliance, CDISC standards, data cleaning, stakeholder collaboration
Preferred skills
CDISC SDTM and ADaM standards knowledge
Technologies
Medidata Rave, Oracle InForm
Responsibilities
Oversee design, build, and testing of clinical databases using EDC systems; Develop and implement data validation specifications and resolve discrepancies; Manage data cleaning activities to ensure timely database lock; Provide technical guidance to team members and study sites; Ensure compliance with regulatory requirements (FDA, EMA, SAHPRA) and industry best practices; Collaborate with statisticians and clinical operations to meet project data requirements
Seniority
Senior, hands-on IC
