Global Study Associate
Core
Supports Global Study Directors and Managers in delivering global clinical studies from set-up through close-out and archiving, ensuring quality, consistency, and regulatory compliance.
Role type
Senior clinical study administrator
Builds
Clinical study execution and regulatory compliance
Domain
Pharmaceutical clinical trials
Required skills
Clinical study lifecycle management, ICH-GCP guidelines, eTMF management, vendor oversight, regulatory document preparation, budget tracking, meeting coordination, presentation creation, process improvement
Preferred skills
Science or clinical research degree, experience training others on study administration
Technologies
eTMF, PharmaCM, regulatory information management systems
Responsibilities
Initiate and lead the set-up of the electronic Trial Master File (eTMF); Provide oversight for non-complex, non-critical path vendors; Contribute to electronic applications/submissions in regulatory information management system; Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity; Support tracking, reconciliation and follow-up of the study budget/payments; Coordinate and provide oversight of administrative tasks and logistical support throughout the conduct of the study, audits and regulatory inspections; Lead the coordination and contribute to the preparation of internal and external meetings.
Seniority
Mid-level, hands-on IC
