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Start-up Specialist

Fortrea

SeoulPosted 6 days agoDirect from company

  • LocationSeoul
  • Work typeNot stated
  • EmploymentFull-time
  • Posted21 October 2026
  • SourceFortrea's careers page (Workday)
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About the role

Job Overview:
The Study Start-Up Specialist supports site start-up activities from potential site identification through site activation, ensuring timely delivery in compliance with applicable regulatory requirements and ICH/GCP guidelines. The role works closely with study teams, internal stakeholders, and site staff to coordinate start-up activities and support successful site activation.

Summary of Responsibilities:

- Coordinate site-level start-up activities from receipt of a potential site list through site activation.

- Collect and manage required site start-up and essential documentation, including CDAs and site questionnaires.

- Support IRB/EC and regulatory submission activities and preparation of study-level essential document templates.

- Manage ICF negotiations and facilitate escalation of issues where required.

- Prepare and submit IMP Release Packages and support other site activation requirements.

- Implement SSU strategies for the assigned region and collaborate with study teams, internal stakeholders, and site staff.

- Track and project site activation timelines, proactively identifying and escalating risks or delays.

- Maintain accurate and timely project status, financial information where applicable, and study information within relevant systems and tools.

- Support consistent implementation of global SSU processes, standards, and tools.

- Ensure all assigned activities are performed in compliance with applicable regulations, guidelines, and ICH/GCP requirements.

Qualifications (Minimum Required):

- BS/BA degree or Associate degree with at least 2 years of experience in healthcare or direct clinical trial-related experience.

- Knowledge of clinical trial conduct, drug development, and ICH/GCP guidelines.

- Strong project management and organizational skills with the ability to manage multiple activities and timelines.

- Excellent interpersonal, written, and verbal communication skills.

- Strong administrative and computer skills.

- Fluent in English.

Physical Demands/Work Environment:

- General Office Environment.

- Minimal travel required (0-5%)

Learn more about our EEO & Accommodations request here .

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