Study Management Associate III
Core
Independent clinical study leader responsible for planning, executing, and managing Phase 0-4 global clinical trials from inception to closure, ensuring quality, efficiency, and compliance with timelines and budget.
Role type
Senior IC clinical study manager
Builds
Global clinical trials (Phase 0-4)
Domain
Biopharmaceuticals / Clinical Research
Required skills
Study-level oversight and leadership, Vendor management (RFP, selection, scope, risk), Global recruitment strategy and execution, Meeting leadership and documentation, Inspection readiness and risk management, Study material development (protocols, submissions, ISF, CSRs), Clinical systems management (EDC, IRT, CTMS, eTMF, ePRO), Investigational product supply management, Training and mentoring
Preferred skills
End-to-end study initiation through completion exposure, Global study exposure
Technologies
EDC, IRT, CTMS, eTMF, ePRO
Responsibilities
Lead cross-functional teams to drive study deliverables and timelines; Manage external vendors and recruitment strategies; Develop and manage study documentation and regulatory submissions; Ensure inspection readiness and manage study risks; Oversee clinical systems and investigational product supplies; Provide training to stakeholders and support process improvements.
Seniority
Senior, hands-on IC
