Study Startup Specialist

Solna - Sweden

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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

This is a full-time remote role based in Sweden Norway or Finland. Native fluency in the local language is required and fluency in two 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.

Required Experience:

Join Fortrea as a Startup Specialist in a sponsor-dedicated role supporting clinical research for one of our key this position you will drive site activation and regulatory submissions ensuring compliance and timely delivery for global studies.This is a full-time remote role based in Sweden Norway...