Study Startup Specialist

Om jobbet

Join Fortrea as aStartup Specialist in asponsor-dedicated role, supporting clinical research for one of our key partners. In this position, you will drive site activation and regulatory submissions, ensuring compliance and timely delivery for global studies.

This is afull-time remote rolebased inSweden, Norway, or Finland. Native fluency in the local language is required, and fluency intwo additional Nordic languages(Swedish, Norwegian, or Finnish) would be a strong advantage, but not mandatory.

As a Startup Specialist, you will:

• Collect and review essential documents to ensure compliance with EC/IRB/Regulatory Authority requirements.
• Prepare and submit regulatory documentation within agreed timelines.
• Act as a local expert on start-up processes and mentor new team members when appropriate.
• Maintain awareness of current regulatory standards and proactively resolve issues.
• Track progress and escalate risks to ensure deliverables are met.
• Participate in team and project meetings and contribute to strategy discussions for site activation.

Required Qualifications

• University/College degree in life sciences or related field, or equivalent experience.
• Minimum 2 years' experience in clinical research, including start-up or regulatory processes in the Nordics.
• Strong knowledge of ICH/GCP guidelines and local regulatory requirements.
• Familiarity with investigator start-up documents and contract/budget negotiation processes.
• Ability to communicate protocol requirements clearly and effectively.

Preferred:

• Experience mentoring or training colleagues.
• Previous interaction with operational project teams and investigative sites.

What We Offer

• Full-time remote position in Sweden or Norway or Finland.
• Opportunity to work on global clinical trials with a leading CRO.
• Collaborative and inclusive work environment.

Learn more about our EEO & Accommodations request here.