Senior Country Start-Up Lead

AbbVie; Ciudad de México; Presencial; MXN 1.060.000 - 1.590.000; Jornada completa

Descripción de la vacante

AbbVie is seeking a Sr. Specialist, Country Study Start Up to drive and execute start-up and maintenance activities for assigned studies and sites in the country. You will ensure on-time delivery, manage activation plans, and mentor SSU Specialists to adopt new processes and tools.

The role requires strong regulatory understanding, experience with IRB/EC processes, and proficiency with Vault SSU for document handling. Collaboration across teams is essential.

Formación

• Minimum 3 years of clinical research experience and 2+ years in study start-up management for the designated region.
• Experience working with central and local IRB/EC sites and ICF approvals.
• Experience using Vault SSU for essential document processing, IP release, and ICF/IRB/EC review.

Responsabilidades

• Ensure successful, on-time, quality start-up and maintenance activities for assigned sites and studies.
• Coordinate with Regulatory and CTS on activation timelines and approvals.
• Attend regional start-up calls and collect essential documents from sites; complete ALCOA checks.
• Lead collaborations with contract managers and site monitors to ensure activation timelines.
• Maintain SSU performance metrics and mentor junior staff.

Conocimientos

Clinical research

Study startup management

Regulatory knowledge

Analytical skills

Vault SSU

Educación

Bachelor Degree in health care or scientific field

Herramientas

Vault SSU

Descripción del empleo

AbbVie is seeking a Sr. Specialist, Country Study Start Up to drive and execute start-up and maintenance activities for assigned studies and sites in the country. You will ensure on-time delivery, manage activation plans, and mentor SSU Specialists to adopt new processes and tools.

The role requires strong regulatory understanding, experience with IRB/EC processes, and proficiency with Vault SSU for document handling. Collaboration across teams is essential.