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ICON plc

Senior Study Start Up Associate – Regulatory Affairs

ICON plc

Senior Study Start Up Associate at ICON responsible for site start-up and regulatory compliance in clinical studies. Leading initiatives to drive quality improvements and patient safety in global healthcare.

Posted 7/7/2026full-timeRemote • 🇰🇷 South KoreaSeniorWebsite

About the role

Key responsibilities & impact
  • Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
  • Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success.
  • Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.
  • Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

Requirements

What you’ll need
  • A Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
  • At least 3 years of experience or understanding of clinical study start-up requirements and activities
  • Fluency in the local language and English is essential

Benefits

Comp & perks
  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools
Feasibility AssessmentSite IdentificationSite Contract NegotiationRegulatory ComplianceInformed Consent DevelopmentClinical Study Start-UpPatient Safety StandardsSubmission PreparationStudy Start Up ExpertiseClinical Research Knowledge
Soft Skills
CollaborationCommunicationProblem-SolvingLeadershipInsightful Contribution