12 ago
|
Icon Clinical
|
Barcelona
12 ago
Icon Clinical
Barcelona
Experteer Overview
In this role you will drive global study start-up activities to enable site activation and timely HA/EC submissions. You will lead SSU planning and cross-country coordination within a growing pharma environment, shaping trial setup and TMF readiness. You’ll manage global timelines, document quality, and vendor interactions to support ambitious recruitment goals. This position offers exposure to international projects and a chance to impact the efficiency of clinical development. You will work closely with cross-functional teams to ensure compliant, scalable start-up processes.
Compensaciones / Beneficios
• Contribute SSU insights to the trial Operational Execution Plan and align SSU strategy with Study Leader/Clinical Trial Team
• Configure and own trial-specific SSU setup (eTMF, milestones, tasks, languages, CTMS, budgeting, site contracting, ICF templates, vendors)
• Lead global SSU planning and team execution from kick-off to SSU completion across all countries and sites
• Ensure timely collection of integral trial documents for HA/EC submission and site activation
• Support Vendor Program Manager to enable timely global vendor activation and submission readiness
• Ensure global Protocol and ICF templates and translations are ready for country use
• Direct the Study Grants Expert for investigator grant plans and country site budget readiness
• Maintain global TMF accuracy and inspection readiness throughout start-up
Responsabilidades
• Must have right to work in UK, Spain, Poland or Bulgaria
• Must have relevant experience in a similar SSU or senior SSU role
• Experience in Clinical Research, Biotech or Pharmaceutical industry
• Able to start within 4-8 weeks
Requisitos principales
• annual leave entitlements
• health insurance
• retirement planning
• Global Employee Assistance Programme
• Life assurance
• flexible country-specific benefits
📌 Study Start-Up Lead (Barcelona)
🏢 Icon Clinical
📍 Barcelona