Global Study Associate CVRM
Core
Supports delivery of global clinical studies from set-up through close-out and archiving, ensuring quality and consistency for BioPharmaceuticals Clinical Operations.
Role type
Senior IC clinical study administrator
Builds
Global clinical studies
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Study administration, eTMF management, regulatory document preparation, clinical trial transparency (CTT) coordination, budget tracking, logistics coordination, meeting coordination, process improvement
Preferred skills
Medical or biological sciences education, study admin/assistant experience, clinical study lifecycle experience
Technologies
eTMF, ANGEL, PharmaCM
Responsibilities
Initiate and lead eTMF set-up and maintenance; create and manage clinical regulatory documents for submissions; coordinate administrative tasks and logistics for audits and inspections; track and reconcile study budget and payments; coordinate study materials and equipment supply; prepare presentation materials for internal and external meetings.
Seniority
Mid-level, hands-on IC
