Study Start-up Specialist (Remote)

Job summary

Responsible for managing study start-up activities in the Netherlands, providing local expertise and ensuring compliance with study timelines and quality standards.

Qualifications

• Bachelor's degree in a relevant scientific field.
• 1-2 years of experience in study start-up within the pharmaceutical or CRO industry.
• Experience in oncology global trials is preferred.
• Fluent in English and Dutch, both written and spoken.

Responsibilities

• Collaborate with the Regional Clinical Operations Manager/Start-up Lead to meet study timelines.
• Identify gaps in processes and propose corrective and preventative actions.
• Manage site performance by tracking regulatory submissions and milestones.
• Ensure inspection readiness of study and site documentation.
• Conduct independent quality reviews of submission packages and manage essential document reconciliation.
• Review and translate relevant documents such as drug labels and recruitment materials.

Skills

• Strong communication and interpersonal skills.
• Excellent organizational skills with the ability to prioritize and multitask.
• Proficient in Microsoft Word, Excel, MS Project, PowerPoint, and Outlook.

Education

• BS in a relevant scientific discipline.

Tools

• Microsoft Office Suite (Word, Excel, MS Project, PowerPoint, Outlook).