25 ott - Varese
Iqvia
Overview
In this role you will monitor clinical sites to ensure study conduct aligns with protocol, GCP, ICH, and sponsor requirements. You will manage site communications, training, and issue escalation, and track regulatory submissions, recruitment, data collection, and TMF/ISF documentation. You’ll collaborate with the study team to support execution and may assist with startup and site recruitment planning. The position involves travel and close attention to quality, timelines, and regulatory compliance.
Retribuzione / Benefits
- health and welfare benefits
- incentive plans may be offered
- career opportunities
Responsabilità
- Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and regulatory requirements
- Drive and track subject recruitment plans to fit project needs
- Administer protocol training to sites and establish regular communication
- Evaluate site practices for protocol integrity and regulatory adherence; escalate quality issues
- Track regulatory submissions, approvals, recruitment, CRF completion, data queries; may support start-up
- Maintain TMF/ISF documentation and ensure regulatory filing requirements
- Create and maintain site management records, visit reports, follow-up letters
- Collaborate with study team for project execution support
- Support development of site-specific recruitment plans; may manage site finances and invoices
Requisiti fondamentali
- Experience in Pharma Industry or Clinical Trials environment
- University Bachelor's and Master's in scientific discipline or health care
- CRA Certification as required by regulations
- Very good computer skills including MS Office
- Excellent command of English
- Organizational, time management and problem-solving skills
- Ability to establish effective working relationships with coworkers, managers, and clients
- Flexibility to travel
- Driver’s license class B
- strong communication
- problem-solving
- time management
- MS Office proficiency
- GCP/ICH knowledge (implied)
- clinical trial documentation (TMF/ISF) management