Senior Country Study Start-Up Leader

AbbVie; Ciudad de México; Presencial; MXN 600.000 - 850.000; Jornada completa

Descripción de la vacante

AbbVie in Mexico City seeks a Sr. Specialist, Country Study Start Up to drive start-up and maintenance activities for assigned studies and sites, ensuring on-time, budget and quality delivery.

Acts as site start-up expert and SME, delivering training and change management in new technologies and processes. You will coordinate regulatory submissions, IP release, site activation, and data collection in Vault SSU, mentor junior staff, and help improve country SSU performance while maintaining audit

Formación

• Bachelor degree in healthcare or scientific field or equivalent experience.
• Minimum 3 years of clinical research experience with study start-up management for the region.
• Experience with central/local IRB/EC processes and ICF routing.
• Experience with Vault SSU for document processing and IP release.
• Strong analytical and risk assessment skills.

Responsabilidades

• Ensure on-time, high-quality start-up and maintenance for sites and studies.
• Lead country/site activation plans with cross-functional teams and regulatory bodies.
• Coordinate IP release, IP shipments, and IXRS activation.
• Maintain SSU performance metrics and regulatory readiness.
• Mentor junior staff and lead training on new technologies.

Conocimientos

Clinical research

Study start up management

Regulatory knowledge

Vault SSU

IRB/EC coordination

Cross-functional collaboration

Educación

Bachelor Degree (healthcare or scientific)

Herramientas

Vault SSU

Descripción del empleo

AbbVie in Mexico City seeks a Sr. Specialist, Country Study Start Up to drive start-up and maintenance activities for assigned studies and sites, ensuring on-time, budget and quality delivery.

Acts as site start-up expert and SME, delivering training and change management in new technologies and processes. You will coordinate regulatory submissions, IP release, site activation, and data collection in Vault SSU, mentor junior staff, and help improve country SSU performance while maintaining audit