Global Study Associate
Core
Support Global Study Leaders and Managers by managing electronic Trial Master Files, regulatory submissions, study logistics, and administrative coordination for clinical trials.
Role type
Study Associate (Clinical Research Operations)
Builds
Clinical trial documentation, regulatory submissions, and study logistics
Domain
Pharmaceutical clinical research
Deliverable
client delivery
Required skills
eTMF management, regulatory document creation, study logistics coordination, budget tracking, meeting coordination, process improvement
Preferred skills
Medical or biological sciences background, ICH/GCP guidelines knowledge, presentation material preparation
Technologies
eTMF systems, ANGEL, PharmaCM, VCV/VQV, SharePoint, BOX, MS Teams, Accord, Coupa, FIND
Responsibilities
Initiate and maintain electronic Trial Master Files (eTMF); Create and manage clinical-regulatory documents for submissions; Coordinate study materials, equipment, and logistics; Track and reconcile study budgets; Prepare presentation materials for study meetings
Seniority
Individual Contributor, operational support
