Spécialiste national, démarrage d’études
Core
Leads and executes proactive study start-up and daily activities for assigned studies and sites, ensuring deliverables, timelines, and quality for clinical trials.
Role type
Senior clinical trial start-up specialist (national/regional)
Builds
Clinical trial launch operations and site readiness
Domain
Clinical research / Healthcare
Required skills
Clinical trial start-up management, ICH GCP guidelines, regulatory compliance, IRB/ethics committee interaction, document quality control (ALCOA), risk assessment, stakeholder coordination, data management systems (Vault Study Start-Up), bilingual communication
Preferred skills
Master's degree in health sciences, >2 years regional start-up management experience, advanced English proficiency
Technologies
Vault Study Start-Up, IXRS
Responsibilities
Develop country-level start-up plans and risk mitigation strategies, coordinate with regulatory affairs and contract management for site approvals, review and submit informed consent forms and patient documents for ethics review, manage investigational product distribution, track start-up activities and KPIs, prepare for audits and inspections, lead process improvement initiatives, mentor national start-up specialists
Seniority
Senior, hands-on IC