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Study Start Up Associate I

icon · Buenos Aires

New
Mid 🇬🇧 English
Clinical Trial Management Systems (CTMS) eTMF

Job description

About the role

ICON Strategic Solutions is hiring a Study Start Up Associate I in Argentina to work in a sponsor-dedicated model, supported by ICON's global expertise. The role facilitates the initiation of clinical trials, ensures compliance with regulatory requirements and contributes to the development of treatments that benefit patients worldwide.

Key responsibilities

  • Coordinate country and site start-up activities against study timelines.
  • Collect, review and track essential regulatory and site documents.
  • Support ethics, regulatory and site submission activities as applicable.
  • Identify start-up risks and follow actions through resolution.
  • Maintain accurate status and documentation in relevant clinical systems.

Required profile

  • Bachelor's degree in life sciences or a related field.
  • Relevant life sciences, healthcare, regulatory or clinical research experience.
  • Experience coordinating site activation, regulatory submissions or essential documents, and country and site start-up activities.
  • Experience supporting ethics, regulatory and site submission activities, and identifying start-up risks.
  • Experience with local ethics committee or regulatory submission requirements in Argentina.
  • Able to review protocols and study documents in both Spanish and English.
  • Preferred: site contract or budget experience, and experience in Clinical Research, Study Start-Up, Site Activation or Regulatory Affairs.

Required skills

  • Knowledge of ICH Good Clinical Practice (GCP) and clinical study start-up processes.
  • Preferred: Clinical Trial Management Systems (CTMS), electronic Trial Master File (eTMF) or start-up platform experience.

What we offer

  • 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 learning and development opportunities.

The position is home-based from Argentina, and employment is contingent on having the legal right to work in the country where the role is based.

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Source : ats:workday

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Published 5 hours ago

Expires 1 month from now

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Buenos Aires