Senior Specialist, Country Study Start-Up Lead

AbbVie; Maidenhead; On-site; GBP 80,000 - 110,000; Full time

Job summary

AbbVie is seeking a Sr. Specialist, Country Start Up to drive and execute start-up and maintenance activities for assigned studies and sites across the country. You will ensure on-time delivery, budget adherence, and quality, acting as a site start-up SME and mentoring junior staff.

In this role you will train teams, manage SSU processes, coordinate with regulatory and monitoring groups, and lead initiatives to shorten start-up cycle times while maintaining compliance with ICH/GCP guidelines.

Qualifications

• Bachelor's Degree in health care or scientific field or equivalent experience.
• Senior clinical research and study start up management experience for the designated region.
• Experience with central and local IRB/EC sites and ICF approvals.
• Knowledge of ICH and GCP guidelines and regulatory environment.

Responsibilities

• Lead start-up and maintenance activities for assigned sites and studies on time and within budget.
• Coordinate with regulatory, CTS, and contract management to align initiation timelines.
• Prepare ethics submissions, ICF customization, and safety reporting.
• Track start-up activities and maintain site databases and KPIs.
• Provide SME training and mentoring in SSU best practices.
• Ensure audit/inspection readiness and compliance with policies.

Skills

Clinical research

Start up management

Cross-functional collab

Regulatory understanding

Education

Bachelor's Degree in health care or scientific field

Tools

Vault SSU

IXRS

ALCOA

Job description

AbbVie is seeking a Sr. Specialist, Country Start Up to drive and execute start-up and maintenance activities for assigned studies and sites across the country. You will ensure on-time delivery, budget adherence, and quality, acting as a site start-up SME and mentoring junior staff.

In this role you will train teams, manage SSU processes, coordinate with regulatory and monitoring groups, and lead initiatives to shorten start-up cycle times while maintaining compliance with ICH/GCP guidelines.