Descrizione:
Experteer Overview
In this role you support the clinical research team to run studies in line with GCP, SOPs, and protocols, while respecting budgets and timelines. You own startup activities and document management, ensuring regulatory submissions and site contracts are handled efficiently. You will maintain trial documentation, CTMS updates, and vendor coordination, contributing to audits and reporting. You join a global, collaborative environment that values courage, accountability, and inclusivity to advance clinical research.
Retribuzione / Benefits
- Oversee startup activities and regulatory submissions at national and international levels under PM oversight
- Manage ISF preparation and TMF setup/maintenance under PM oversight
- Maintain relationships with Ethics Committees and Competent Authorities
- Support sites/vendors invoicing management and tracking
- Collaborate on weekly/monthly project reports and update CTMS and trackers
- Support CRAs activities follow-up and document translation as needed
- Participate in internal, client/sponsor, scientific meetings and audits
- Perform additional duties as assigned
Responsabilità
- Graduation in scientific/health field
- Experience in clinical research (CROs, Pharma, or academic/hospital)
- Good knowledge of ICH GCP and applicable regulations
- Understanding of Clinical Research and Regulatory/Ethical requirements
- English proficiency
- MS Office Suite proficiency
- Strong organizational, multi-tasking, and time management skills
- Strong analytical, communication, and interpersonal skills with customer service orientation
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