Senior Clinical Start-Up Specialist

11 Premier Research International LLC; Argentina; Presencial; ARS 900.000 - 1.300.000; 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 help transform ideas and drive start-up activities across biotech, medtech, and pharma projects, enabling timely trials and patient access.

This role requires strong regulatory knowledge, English communication, and a collaborative mindset to coordinate with Project Managers, Regulatory Start-up Leads, and local authorities.

Formación

• Bachelor's degree or international equivalent in a clinical, science, or health-related field.
• 5+ years of direct start up experience.
• Thorough knowledge of FDA Guidance Documents / EU Directives / Local Regulations / ISO14155.
• Knowledge of country-specific regulatory requirements for clinical trials.
• Excellent teamwork and cross-functional collaboration.
• Strong verbal and written English communication skills.

Responsabilidades

• Forecasts submission/approval timelines and ensures they are adhered to.
• Provides rationale for delays, contingency plans, and escalates issues as needed.
• May serve as primary contact for PM, Clinical Lead, Regulatory Start-up Manager during start-up.
• Prepares submissions and amendments required by EC/IRB per local rules.
• Submits end of study notifications to ECs/IRBs and local authorities.
• Oversees essential document collection/review to ensure sponsor/investigator obligations meet local requirements.
• Local contract/budget negotiation for site contracts where applicable.
• Reviews informed consent templates and other patient documents for the country.
• Supports start-up strategy development at proposal stage to support business opportunities.

Conocimientos

Strong English communication

Team player

Educación

Bachelor's degree or international equivalent

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 help transform ideas and drive start-up activities across biotech, medtech, and pharma projects, enabling timely trials and patient access.

This role requires strong regulatory knowledge, English communication, and a collaborative mindset to coordinate with Project Managers, Regulatory Start-up Leads, and local authorities.