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Study Start Up Associate II

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Location:
South Korea , Seoul

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

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Job Description:

We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNvative treatments and therapies.

Job Responsibility:

  • Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
  • Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
  • Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
  • Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities
  • Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency

Requirements:

  • Bachelor's degree in life sciences or a related field
  • Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
  • Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
  • Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
  • Initial and Amendment for IRB Submission
What we offer:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Additional Information:

Job Posted:
February 19, 2026

Work Type:
Remote work
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