Site Start-Up Specialist (Remote)

Job summary

This role involves coordinating site start-up activities for clinical trials, ensuring regulatory compliance, and managing essential documentation. The position is fully remote and focuses on supporting start-up activities across Finland, Sweden, and Norway.

Qualifications

• University/College degree in life sciences or certification in a related health profession.
• Minimum of 2 years of experience in clinical research, regulatory submissions, or site activation.
• Strong understanding of ICH/GCP guidelines, regulatory authority, and site start-up processes.
• Fluency in both Swedish and Finnish, as well as English.

Responsibilities

• Act as the primary contact for investigative sites during start-up and maintenance activities.
• Collect, review, and organize documents for regulatory submissions.
• Ensure compliance with ICH/GCP guidelines and sponsor specifications.
• Prepare and submit regulatory documents, including application forms and informed consent forms.
• Track submission timelines and address potential delays proactively.
• Collaborate with stakeholders, including vendors and clinical teams.
• Maintain audit-ready documentation and update systems consistently.
• Assist in negotiating site contracts and budgets when applicable.
• Mentor and train new hires and less-experienced colleagues.

Skills

What We Offer

• Excellent organizational, problem-solving, and communication skills.
• Proficiency in Microsoft Office and document management systems.
• Competitive salary and performance-based incentives.
• Flexible work arrangements.
• Opportunities for professional growth in a collaborative environment.
• Involvement in innovative clinical research projects.