Study Management Associate III
Core
Execute global Phase 0-4 clinical trials from inception to closure, ensuring quality, efficiency, and compliance with timelines and budget.
Role type
Senior clinical study manager (IC)
Builds
Global clinical trial execution and delivery
Domain
Pharmaceutical clinical research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Study-level oversight and leadership, Vendor management (RFP, selection, oversight), Global recruitment strategy and execution, Meeting leadership and documentation, Risk identification and mitigation, Study material development and management, Clinical trial systems proficiency (EDC, IRT, CTMS, eTMF), Investigational product supply management, Training delivery, Process improvement
Preferred skills
End-to-end study initiation to completion exposure, Global study exposure
Technologies
EDC, IRT, CTMS, eTMF
Responsibilities
Lead cross-functional teams for study strategy and execution, Manage external vendors and recruitment strategies, Ensure inspection readiness and risk management, Develop and manage study protocols and regulatory submissions, Manage clinical trial systems and investigational product supplies, Provide training to stakeholders and support process improvements
Seniority
Senior, hands-on IC
