Senior Clinical Data Manager I
Core
Coordinates Clinical Data Management (CDM) deliverables for assigned clinical studies, ensuring data integrity from build through lock to support regulatory submissions.
Role type
Senior Individual Contributor Clinical Data Manager
Builds
Clean, validated clinical datasets for regulatory submissions and clinical insights
Domain
Pharmaceutical/Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Clinical Data Management (CDM), Good Clinical Data Management Practices (GCDMP), query management, data cleaning and reconciliation, clinical database systems, EDC systems, regulatory compliance, risk identification and mitigation, vendor management, study lifecycle management (startup, conduct, closeout), mentoring
Preferred skills
Drug development process knowledge, clinical data system design and validation, SQL/4GL/VBA/R programming, external partner collaboration
Responsibilities
Coordinate CDM deliverables and oversee day-to-day operational aspects of assigned studies; manage query resolution and data reconciliation; ensure compliance with Trial Master File and CDM standards; provide input for regulatory inspections; mentor junior colleagues; manage risks and project timelines
Seniority
Senior, hands-on IC