Associate Director, Clinical Data Management
Core
Lead clinical data management programs and teams to ensure high-quality data delivery for late-phase clinical trials and regulatory submissions.
Role type
Senior IC clinical data management program lead
Builds
Clinical trial data sets for regulatory filings (NDA/BLA/MAA)
Domain
Biopharmaceuticals / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical drug development process knowledge, ICH/regulatory guidelines (EMEA/FDA), EDC systems (Medidata RAVE), project management, metrics analysis, change management
Preferred skills
Managing late-phase studies, portfolio management, PMP certification
Technologies
Medidata RAVE, Microsoft Office
Responsibilities
Provide oversight of a program of studies and Data Management Leads; Establish governance frameworks for risk monitoring; Manage resource assignments and forecast future needs; Lead or support Health Authority inspections and audits; Author and review DM study plans and quality management documents; Provide oversight for FSP/CRO/Vendor data management deliverables.
Seniority
Senior, hands-on IC with line management
