Clinical Trial Start-Up Specialist: Regulatory & Sites

BeiGene, Ltd.; España; A distancia; EUR 46.000 - 58.000; Jornada completa

Descripción de la vacante

BeOne seeks a Startup Specialist to manage and coordinate all activities related to the start-up of clinical trials at multiple sites. The role ensures timely initiation, regulatory compliance, and quality standards are met across countries.

You will translate documents, oversee essential study materials, and work with investigators to retrieve critical documents, driving startup milestones and inspection readiness.

Formación

• Bachelor's degree in Life Sciences, Pharmacy, Biomedicine, or related field.
• Minimum 2 years of experience in the pharmaceutical industry, startup role preferred.
• Strong understanding of regulatory processes and ICH guidelines.
• Fluent in English, Spanish, and Portuguese (writing and speaking).

Responsabilidades

• Plan, coordinate, and oversee the start-up of clinical studies across multiple sites.
• Collaborate with Regional Submission Lead to meet start-up milestones and regulatory needs.
• Translate informed consent forms and country-specific study templates.
• Manage essential documents and site file reconciliation with investigators.
• Support budget and contract negotiations, and manage amendments.

Educación

Bachelor's degree in Life Sciences/Pharmacy/Biomedicine

Herramientas

MS Project

Excel

Word

PowerPoint

Outlook

Descripción del empleo

BeOne seeks a Startup Specialist to manage and coordinate all activities related to the start-up of clinical trials at multiple sites. The role ensures timely initiation, regulatory compliance, and quality standards are met across countries.

You will translate documents, oversee essential study materials, and work with investigators to retrieve critical documents, driving startup milestones and inspection readiness.