Project Support Specialist
Core
Coordinates project support staff, manages system metrics, and ensures audit readiness and compliance for clinical studies.
Role type
Senior Project Support Specialist (Clinical Trials)
Builds
Operational performance, audit-ready study environments, compliance reports, and study plans
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
eTMF management, risk assessment, process improvement, audit preparation, client coordination, system metrics analysis, study plan preparation, training compliance oversight
Preferred skills
Experience with Clarity platform, experience as lead on eTMF activities, experience with client eTMF platforms
Technologies
eTMF platforms, Clarity
Responsibilities
Handle metrics in various systems, coordinate and support assigned PSS staff, support creation and implementation of process improvements, provide oversight on study level activities, prepare client compliance reports and slides for CRA meetings, act as oversight on eTMF-specific activities including filing and file review
Seniority
Senior, hands-on IC

