Experteer Overview
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In this role you will manage site activation and start-up processes within country level requirements, ensuring timely regulatory submissions and documentation. You will collaborate with cross-functional teams across clinical solutions to support trial initiation and site readiness. You help ensure quality, compliance, and efficient communication with sites and authorities, enabling smooth study start-up and site activation. This position offers working in a hybrid model in Madrid, contributing to a mission-driven healthcare impact. You will help shape start-up delivery at scale while supporting continuous improvement in SSU components.
Compensaciones / Beneficios
• Ensure quality deliverables at the country level and track submission timelines using the SSU tracking system
• Monitor project finances and escalates discrepancies promptly
• Adhere to SOPs/WIs and maintain training records and timesheet compliance
• Support ongoing quality improvements in Site Start-Up components
• Submit documentation to Trial Master File per SOP/Sponsor requirements
• Serve as Local Submissions Specialist, coordinating EC/RA applications and local regulatory submissions
• Coordinate local and central submissions, amendments, and regulatory notifications with oversight
• Facilitate liaison between investigational sites and functional leads; oversee end-to-end site activation
• Act as Country Start-Up Advisor, maintaining regulatory intelligence and advising on local legislation and data protection considerations
• Assist with site identification, feasibility, and potential Investigator Contract/Budget negotiation as needed
Responsabilidades
• Bachelor's Degree
• Over 2 years of experience in Site Activation / Start-Up or related role
• Knowledge of clinical trial processes across Phases II-IV and ICH GCP
• Understanding of start-up processes and xpzdshu regulatory submissions
• Ability to manage external vendors and contracts
• Strong organizational, written and verbal communication, and interpersonal skills
• Experience managing multiple budgets with increasing complexity
• Quality-focused, with good problem-solving and negotiation abilities
• Ability to work independently and as part of a team
Requisitos principales
• career development
• technical and therapeutic area training
• peer recognition
• total rewards program
• supportive line management
• inclusive culture
Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.