Associate, Study Management III/CTM III
Core
Independent clinical study leader responsible for planning, executing, and managing global Phase 0-4 clinical trials from inception to closure, ensuring quality, efficiency, and compliance with timelines and budget.
Role type
Senior IC clinical study manager (CTM)
Builds
Global clinical trials across multiple therapeutic areas
Domain
Biopharmaceuticals / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, vendor management, global recruitment strategy, risk identification and mitigation, regulatory compliance (ICH/GCP), system management (EDC, IRT, CTMS, eTMF), stakeholder engagement, inspection readiness, process improvement
Preferred skills
End-to-end study initiation through completion experience, global study exposure
Technologies
EDC, IRT, CTMS, eTMF
Responsibilities
Lead cross-functional teams to drive study deliverables and timelines; manage external vendors including RFPs and scope of work; execute global recruitment strategies; lead meetings and manage study documentation; ensure inspection readiness and risk management; manage clinical study systems and supplies; provide training to stakeholders.
Seniority
Mid-Senior, hands-on IC
