End-to-End Site Activation & Regulatory Expert

Worldwide Clinical Trials; Municipio de Rincón de los Sauces; Presencial; ARS 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials in Argentina is seeking a Regulatory Start-Up Specialist to support end-to-end site activation and maintenance for awarded projects. You will coordinate documents, timelines, and country-specific regulatory needs to help sites activate efficiently.

The role requires at least a two-year life sciences degree, 2+ years in clinical research, and strong organizational skills. English knowledge preferred; multilingualism is a plus.

Formación

• Two-year college degree in life sciences or related field.
• Minimum 2 years of experience in clinical research.
• Multilingualism preferred; fluent in local language; working knowledge of English.

Responsabilidades

• Support end-to-end site start-up from site identification to activation and maintenance.
• Act as country-level regulatory and site activation contact for assigned studies.
• Customize country-specific patient information sheets, informed consent forms and labels to comply with ICH GCP and country requirements.
• Review country timelines and provide status updates to RAM and project team.
• Track study regulatory documents by site/country and report to RAM; identify risks and mitigation strategies.

Conocimientos

Regulatory start-up

Site activation

Project coordination

Multilingual

Educación

Two-year college degree in life sciences

Herramientas

MS Office

Regulatory databases

Descripción del empleo

Worldwide Clinical Trials in Argentina is seeking a Regulatory Start-Up Specialist to support end-to-end site activation and maintenance for awarded projects. You will coordinate documents, timelines, and country-specific regulatory needs to help sites activate efficiently.

The role requires at least a two-year life sciences degree, 2+ years in clinical research, and strong organizational skills. English knowledge preferred; multilingualism is a plus.