Analista Sr Start-up Estudos Clinicos
Core
Coordinate and execute clinical supply import and shipping activities for clinical studies, ensuring timely delivery and regulatory compliance.
Role type
Senior Clinical Study Start-Up Analyst (Supply Chain)
Builds
Clinical study supply chains and regulatory submission packages
Domain
Clinical research / Pharmaceutical supply chain
Required skills
Clinical supply chain management, regulatory compliance (ICH/GCP), stakeholder coordination, risk management, documentation review, ALCOA principles, system data entry
Preferred skills
Study Start-Up experience, remote team collaboration, process improvement, multi-priority management
Technologies
Internal study management systems, logistics tracking tools
Responsibilities
Coordinate import and shipping of clinical supplies and investigational products; Review documentation for completeness and accuracy; Monitor import timelines and proactively identify risks; Ensure alignment with regulatory approvals; Maintain accurate records for audits; Support local ethics committee and regulatory submissions; Participate in multi-functional Study Start-Up meetings.
Seniority
Senior, hands-on IC
