Senior Clinical Start-Up Lead (Remote - Argentina)

Premier Research Group; Argentina; Remote; ARS 90,953,000 - 151,589,000; Full time

Job summary

Premier Research is seeking a Senior Site Start up Associate to join the Clinical Monitoring, Site Management and SSU team in Argentina. This remote role supports biotech, medtech and specialty pharma projects, coordinating start-up submissions, regulatory alignments, and contract activities across local authorities.

You will work with Project Managers and Regulatory Leads, ensuring timelines are met and documents are compliant.

Qualifications

• 5+ years of direct start-up experience.
• Thorough knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations.
• Knowledge of country-specific regulatory requirements for clinical trials.

Responsibilities

• Forecasts submission/approval timelines and ensures adherence.
• Prepares submissions and amendments for EC/IRB as required by local rules.
• Reviews essential documents to ensure sponsor/ investigator obligations are met.
• Negotiate site contracts and budgets with investigators and Contracts Lead.

Skills

Start-up experience

English communication

Team collaboration

Project coordination

Education

Undergraduate degree or international equivalent in clinical/science/health

Job description

Premier Research is seeking a Senior Site Start up Associate to join the Clinical Monitoring, Site Management and SSU team in Argentina. This remote role supports biotech, medtech and specialty pharma projects, coordinating start-up submissions, regulatory alignments, and contract activities across local authorities.

You will work with Project Managers and Regulatory Leads, ensuring timelines are met and documents are compliant.