Remote Clinical Site Start-Up Specialist

FTSWE Fortrea Development Ltd Sverige filial; Solna kommun; On-site; SEK 420,000 - 600,000; Full time

Benefits offered by this job

Remote work

Flexible schedule

Professional growth

Job summary

Fortrea is seeking a Site Start-Up Specialist to coordinate site activation, manage essential regulatory documents, and ensure timely submissions across Sweden, Finland, and Norway. This full-time, home-based role supports our FSPx team and a leading sponsor, driving regulatory excellence and patient access.

You will review and organize documents, liaise with regulatory authorities, sites, and vendors, and mentor teammates, all while maintaining audit-ready systems and compliant start-up

Qualifications

• Minimum 2 years in clinical research, regulatory submissions, or site activation.
• Strong knowledge of ICH/GCP guidelines and RA regulations.
• Experience coordinating with regulatory authorities and sites.
• Fluency in local language and English.

Responsibilities

• Serve as primary contact for investigative sites during start-up and maintenance activities.
• Prepare, review, and submit regulatory documents and informed consent forms.
• Track submission timelines and ensure audit-ready documentation.

Skills

Regulatory submissions

ICH/GCP knowledge

Site activation

Document management

Communication skills

Education

University degree in life sciences

Tools

Microsoft Office

Document management systems

Job description

Fortrea is seeking a Site Start-Up Specialist to coordinate site activation, manage essential regulatory documents, and ensure timely submissions across Sweden, Finland, and Norway. This full-time, home-based role supports our FSPx team and a leading sponsor, driving regulatory excellence and patient access.

You will review and organize documents, liaise with regulatory authorities, sites, and vendors, and mentor teammates, all while maintaining audit-ready systems and compliant start-up