Study Startup Specialist

3 days ago

Solna Municipality, Sweden Fortrea Full time 90,000 - 130,000 per year

Join Fortrea as a
Startup Specialist
in a
sponsor-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 a
full-time remote role
available to candidates based in
Sweden or Norway
.

As a Startup Specialist, You Will

  • Serve as the primary contact for investigative sites during start-up and maintenance activities.
  • 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.
  • 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.
  • Opportunity to work on global clinical trials with a leading CRO.
  • Collaborative and inclusive work environment.

Learn more about our EEO & Accommodations request here.

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