Homebased Clinical Trials Site Activation Lead

Fleni Centro Médico; Buenos Aires; Presencial; ARS 135.820.000 - 196.185.000; Jornada completa

Descripción de la vacante

Fleni Centro Médico is seeking a Clinical Trial Coordinator II to direct and manage site activation, maintenance, and regulatory activities for multiple protocols and studies. The role emphasizes collaboration across regions, budget oversight, and ensuring compliance with regulatory requirements.

The candidate will lead the preparation of regulatory submissions, manage timelines, and mentor team members while maintaining high-quality documentation and supporting business development activities.

Formación

• Bachelor's degree in life sciences or related field.
• 7 years' experience in a scientific or clinical environment including international role.
• Strong negotiation and communication skills.
• Excellent knowledge of GCP and ICH guidelines.
• Ability to manage multiple projects and timelines.

Responsabilidades

• Oversee site activation and maintenance activities per RSU plan and timelines.
• Develop and maintain project documentation and regulatory submissions.
• Provide regulatory and scientific support to enable trials and compliance.
• Mentor colleagues and coordinate with cross-regional teams.
• Maintain CTMS, tracking tools, and project plans.

Conocimientos

Negotiation skills

Communication skills

Leadership

Presentation skills

Team collaboration

Regulatory knowledge

Educación

Bachelor's degree life sciences or related field

Herramientas

CTMS

MS Office

Regulatory writing tools

Descripción del empleo

Fleni Centro Médico is seeking a Clinical Trial Coordinator II to direct and manage site activation, maintenance, and regulatory activities for multiple protocols and studies. The role emphasizes collaboration across regions, budget oversight, and ensuring compliance with regulatory requirements.

The candidate will lead the preparation of regulatory submissions, manage timelines, and mentor team members while maintaining high-quality documentation and supporting business development activities.