24 ott - Monza
Iqvia
OverviewIn 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 / Benefitshealth and welfare benefitsincentive plans may be offeredcareer opportunitiesResponsabilitàPerform site monitoring visits (selection, initiation, monitoring, close-out) per scope and regulatory requirementsDrive and track subject recruitment plans to fit project needsAdminister protocol training to sites and establish regular communicationEvaluate site practices for protocol integrity and regulatory adherence; escalate quality issuesTrack regulatory submissions, approvals, recruitment, CRF completion,
data queries; may support start-upMaintain TMF/ISF documentation and ensure regulatory filing requirementsCreate and maintain site management records, visit reports, follow-up lettersCollaborate with study team for project execution supportSupport development of site-specific recruitment plans; may manage site finances and invoicesRequisiti fondamentaliExperience in Pharma Industry or Clinical Trials environmentUniversity Bachelor's and Master's in scientific discipline or health careCRA Certification as required by regulationsVery good computer skills including MS OfficeExcellent command of EnglishOrganizational, time management and problem-solving skillsAbility to establish effective working relationships with coworkers, managers, and clientsFlexibility to travelDriver's license class Bstrong communicationproblem-solvingtime managementMS Office proficiencyGCP/ICH knowledge (implied)clinical trial documentation (TMF/ISF) management