Site Management Lead
Core
Lead Clinical Site Management (CSM) integrity, quality, and timeliness for assigned clinical studies, acting as a study strategy leader or area site execution manager.
Role type
Senior Clinical Site Management Lead
Builds
Global and area-level site monitoring strategies, engagement plans, and study execution deliverables
Domain
Clinical Research / Pharmaceutical
Required skills
Clinical trial management, site monitoring strategy, risk assessment and mitigation, study lifecycle management, stakeholder alignment, compliance management, resource planning, inspection readiness, data cleaning coordination, protocol adherence
Preferred skills
Multi-phase study experience (Phase I-III), multiple therapeutic areas, matrix environment leadership, presentation skills
Technologies
Microsoft Office Suite (Word, PowerPoint, Excel, OneNote)
Responsibilities
Drive global/area CSM deliverables by targeted timelines; Analyze study timelines to confirm feasibility; Support CSM resource needs with Country Leaders; Accountable for site monitoring strategy and Site Engagement Strategy; Maintain study-level timelines across lifecycle; Drive site-level activities (selection, activation, engagement, close out); Oversee monitoring activities ensuring quality and milestone adherence; Drive CSM deliverables during data snapshots and database locks; Ensure sites are closed per Site Closure Plan; Identify, evaluate, and mitigate risks; Collaborate on Risk Assessment and Mitigation Plan (RAMP); Ensure site compliance and analyze trends; Provide inputs on CSM documents and drive TMF completeness; Ensure ongoing CSM Inspection Readiness activities.
Seniority
Senior, hands-on IC
