Senior Manager, Study Operations Lead
Core
Leads the Evidence Generation Study Operations team, overseeing operational execution for fair market value (FMV) process support, study documentation, close-out, and site-based/non-site-based study support.
Role type
Senior Manager, Study Operations Lead
Builds
Operational support for Global Evidence Generation studies and cross-functional partners
Domain
Biopharmaceutical / Clinical Research Operations
Required skills
Study lifecycle management, FMV process execution, contracting coordination, repository governance, team leadership, stakeholder management, operational risk monitoring, process standardization, quality oversight, escalation management
Preferred skills
Advanced degree in life sciences or business operations, 7+ years experience (4+ in biopharma), experience with iEnvision Research Module, Veeva Vault, ERP or procurement tools, AI-enabled tool usage
Technologies
iEnvision Research Module, Veeva Vault, ERP, procurement tools
Responsibilities
Manage daily workflow, capacity planning, and performance for Operations Enablement Leads; Establish operating rhythms, escalation pathways, and handoff protocols; Oversee FMV documentation, study reporting, close-out, and vendor artifact storage; Coordinate with Finance, Legal, Compliance, and vendors; Monitor operational risks and drive corrective actions; Coach and develop team members; Serve as primary point of contact for study operations reporting
Seniority
Senior Manager, hands-on leadership
