IQVIA
clinical research services, commercial insights and healthcare intelligence
PrincipalClinicalDatabaseManager
“Principal Clinical Database Manager at IQVIA. Skills: Database Design, Clinical Data Management, Medidata RAVE. Interpret the study protocol. Design and update eCRF”
Industry & Context.
Based in Latinamerica, home base role
What They're Looking For.
Must Have
Bachelor's Degree in Science/Computer science/Information or Technology, 4 to 6 years of relevant core technical designer experience, 9 years of overall experience in clinical research data management, Hands-on experience designing in Medidata RAVE
What You'll Do.
Interpret the study protocol
Design and update eCRF
Create and update Edit Specification Document
Generate specifications for EDC build
Complete Study Authorization Form
Attend Pre-Design Meeting
Facilitate Edit Specification Review Meeting
Design the database for LLRR data
Communicate project risks
Escalate potential quality issues
Ensure project-specific training completion
Review build timelines
Review QIP for own projects
Manage multiple study design projects
Identify process improvements
How You'll Work.
Team & Collaboration
Collaborate with DTL, Programmer, Validation Team, vendors, statisticians, and client representatives; Communicate project risks to Data Team Lead; Inform relevant parties of out of scope activities
Communication Scope
Present comments at Internal Design Review Meeting; Lead discussions regarding Edit Specification Document; Communicate project risks
Process & Methodology
Manage multiple study design projects
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