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Fortrea via Workday

Site Start-up Specialist - FSP

Sweden Level not stated
still open verified 16h ago posted 14d ago seen 1h ago
Apply at fortrea.wd1.myworkdayjobs.com

This is the employer's own posting, not a copy on a job board.

What we know

Is it still open?

Confirmed still open

Last checked 16h ago — checked against the employer's own applicant tracking system, which is the company answering directly.

We re-read the employer's own applicant tracking system and the posting was still there. That is the company answering directly.

Check this listing's status as JSON

How old is it?

Posted 14d ago

The date the source published, not the day we noticed it (2026-09-18). Last seen at its source 1h ago.

We have tracked this listing since 22 Sep 2026 (9 days). The employer's own board has carried it every time we have read it, most recently 1 hour ago.

Is it remote?

The listing says yes

The location field doesn't say remote, so our assessment is based on the title or the description. Read the listing before applying.

Who may apply?

Sweden

The description states no restriction of its own. This is the source's own tag.

Skills named in the ad

MentoringNegotiationRegulatory Compliance

Recognised terms only, from a fixed vocabulary — this is what CV matching compares against.

Carried by 1 source

The listing

Join Our Team and Drive Clinical Research Success!

At Fortrea, we are committed to accelerating clinical trials and ensuring regulatory compliance. As a Site Start-Up Specialist, you will play a pivotal role in coordinating site start-up activities, managing essential documents, and ensuring regulatory submissions are completed efficiently. Your expertise will help bring life-changing treatments to patients faster.

In this role, you will be part of our FSPx team and work directly with one of our renowned key sponsor to advance the development of innovative, life-changing medications.

This is full time, permanent and home based position.

Preferred Candidate Profile:

Fluency in both Swedish and Finnish, or able to support start-up activities across Finland, Sweden and Norway.

Key Responsibilities:

In this role, you will:

  • Serve as the primary contact for investigative sites during start-up and maintenance activities.

  • Collect, review, and organize essential documents required for regulatory submissions (EC/IRB/Third Body/Regulatory Authority).

  • Ensure compliance with ICH/GCP guidelines, regulatory requirements, and sponsor specifications.

  • Prepare and submit regulatory documents, including country-specific application forms and informed consent forms.

  • Track submission timelines and proactively address potential delays.

  • Collaborate with internal and external stakeholders, including vendors, clinical teams, and regulatory authorities.

  • Ensure all documentation is audit-ready and systems are consistently updated.

  • Assist in the negotiation of site contracts and budgets, if applicable.

  • Provide mentorship and training to new hires and less-experienced colleagues.

Required Qualifications:

To succeed in this role, you should have:

  • University/College degree (life sciences preferred) or certification in a related allied health profession.

  • Minimum 2 years of experience in clinical research, regulatory submissions, or site activation.

  • Strong knowledge of ICH/GCP guidelines, RA, IRB/IEC regulations, and start-up processes.

  • Ability to review and adapt patient informed consent forms to meet local and protocol-specific requirements.

  • Experience interacting with regulatory authorities and site start-up teams.

  • Excellent organizational, problem-solving, and communication skills.

  • Proficiency in Microsoft Office and document management systems.

  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

  • Fluency in local language and English.

What We Offer:

  • Competitive salary and performance-based incentives.

  • Flexible work arrangements (remote/hybrid options).

  • Professional growth opportunities in a collaborative and innovative environment.

  • The opportunity to work on cutting-edge clinical research projects.

Ready to Make an Impact?

Join us in shaping the future of clinical research. Apply today!

Applications are reviewed on a rolling basis—don’t miss this opportunity!

#LI-Remote

Learn more about our EEO & Accommodations request here.

Apply at fortrea.wd1.myworkdayjobs.com