Senior Country Study Start-Up Expert

BioSpace; Shanghai (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

AbbVie is seeking a Sr. Specialist, Country Start Up, to drive and execute country start-up and maintenance activities for assigned studies and sites. You will act as a subject-matter expert, mentoring specialists and ensuring on-time, high-quality delivery across complex protocols and multiple sites.

The role requires strong regulatory know-how, robust project coordination, and experience with Vault SSU. It offers growth in process improvements and cross-functional leadership within a global

Qualifications

• Minimum 3 years of clinical research experience and 2+ years in study start up management for designated region.
• Experience working with central and local IRB/EC sites and reviewing ICFs for approval.
• Familiarity with ICH and GCP guidelines and country regulatory environment.

Responsibilities

• Ensure on-time, quality execution of start-up and maintenance activities for sites and studies.
• Coordinate with Regulatory and CTS on submissions and approvals to align with activation timelines.
• Track start-up and maintenance activities and provide updates to leadership.

Skills

Clinical research

Project coordination

Regulatory knowledge

Analytical thinking

Education

Bachelor's Degree in health care or scientific field

Tools

Vault SSU

Job description

AbbVie is seeking a Sr. Specialist, Country Start Up, to drive and execute country start-up and maintenance activities for assigned studies and sites. You will act as a subject-matter expert, mentoring specialists and ensuring on-time, high-quality delivery across complex protocols and multiple sites.

The role requires strong regulatory know-how, robust project coordination, and experience with Vault SSU. It offers growth in process improvements and cross-functional leadership within a global