Study Project Manager II
Core
Drives connection between asset and operational delivery, executing clinical research studies with quality, efficiency, and on-time completion.
Role type
Senior IC clinical study project manager
Builds
Clinical research studies (Phase 1-4 drug and/or device studies)
Domain
Clinical research / Pharmaceutical
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
End-to-end clinical study operations management, Strategic asset-level thinking, Cross-functional team leadership, Vendor oversight and contract review, Risk identification and mitigation, ICH/GCP and Global Regulations compliance, Clinical trial systems expertise (EDC, IRT, CTMS, eTMF)
Preferred skills
Drug, device, interventional, and non-interventional study experience, Early feasibility study experience, Process improvement and innovation
Technologies
EDC, IRT, CTMS, eTMF
Responsibilities
Link asset-level goals with study-level operational strategies, Lead cross-functional teams to drive milestone achievement, Provide oversight on vendor selection and contract review, Proactively identify and mitigate study-related risks, Coach and mentor team members, Identify and lead process improvements for operational efficiencies
Seniority
Senior, hands-on IC
