Hybrid Country Study Start-Up Specialist

AbbVie; Hoofddorp; Hybrid; EUR 50,000 - 75,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

AbbVie is seeking a Country Study Start-Up Specialist to lead country- and site-level start-up and maintenance activities for assigned clinical trials, ensuring timely activation and compliance with ICH-GCP and local regulations.

You will collaborate with Clinical Operations, Regulatory Affairs, Contract Management, and other teams, maintain essential documents, coordinate submissions and approvals, and support audit readiness.

Qualifications

• Fluency in Dutch language required.
• Bachelor’s degree or equivalent qualification; health-related degree preferred.
• At least 1–2 years of clinical research experience.
• Experience with remote or virtual teams.
• Knowledge of ICH GCP and local regulatory environment.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong analytical, interpersonal, and communication skills.
• Ability to build trust with diverse stakeholders.

Responsibilities

• Lead start-up and maintenance activities for studies and sites, ensuring timely delivery, quality, and compliance.
• Develop country and site activation plans and support risk assessment with cross-functional teams.
• Identify issues affecting delivery and communicate solutions.
• Coordinate country submissions, approvals, clinical supplies, and activation requirements.
• Maintain essential documents in accordance with ALCOA principles and local standards.
• Prepare ethics committee packages, informed consent forms and patient materials.
• Track study and site performance metrics and provide updates to stakeholders.
• Support audit readiness and AbbVie policy compliance.

Skills

Dutch fluency

Analytical skills

Critical thinking

Interpersonal skills

Communication skills

multitasking

Education

Bachelor's degree

Health-related degree preferred

Job description

AbbVie is seeking a Country Study Start-Up Specialist to lead country- and site-level start-up and maintenance activities for assigned clinical trials, ensuring timely activation and compliance with ICH-GCP and local regulations.

You will collaborate with Clinical Operations, Regulatory Affairs, Contract Management, and other teams, maintain essential documents, coordinate submissions and approvals, and support audit readiness.