Senior Clinical Start-Up Lead

Premier Research; Argentina; Presencial; ARS 45.273.000 - 63.383.000; Jornada completa

Descripción de la vacante

Premier Research is seeking a Senior Site Start up Associate to join our Clinical Monitoring, Site Management and SSU team. You will support global biotech and pharma sponsors by coordinating start-up activities, ensuring timelines, and maintaining regulatory alignment.

You will work closely with Project Managers, Regulatory Start-up Managers, and local authorities to prepare submissions, review essential documents, and negotiate site contracts while safeguarding patient safety and data

Formación

• Undergraduate degree in clinical, science or health field.
• 5+ years of direct start-up experience.
• Knowledge of FDA/EU regulations and ISO14155 for trials.
• Familiarity with country-specific regulatory requirements.
• Experience creating and reviewing informed consent templates.
• Strong team collaboration and problem-solving abilities.
• Excellent verbal and written English communication.

Responsabilidades

• Forecasts submission timelines and ensures adherence with clear contingency plans.
• Prepares submissions and amendments for EC/IRB as required.
• Oversees document collection to meet sponsor and regulatory obligations.
• Negotiates site contracts and budgets with sites and Contracts Lead.
• Reviews informed consent templates and other patient documents.
• Supports start-up strategy development for proposals.

Conocimientos

Clinical start-up

Regulatory knowledge

English communication

Team collaboration

Educación

Bachelor's degree in clinical/health field

Descripción del empleo

Premier Research is seeking a Senior Site Start up Associate to join our Clinical Monitoring, Site Management and SSU team. You will support global biotech and pharma sponsors by coordinating start-up activities, ensuring timelines, and maintaining regulatory alignment.

You will work closely with Project Managers, Regulatory Start-up Managers, and local authorities to prepare submissions, review essential documents, and negotiate site contracts while safeguarding patient safety and data