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Global drug and device development services

Study Start Up Associate 1

Clinical Research OperationsPosted on Nov 12
Full-timeBuenos Aires, ArgentinaNo salary listed

About the Job

Requirements

  • A bachelor's degree in life sciences or a related field is required.
  • Relevant life sciences, healthcare, regulatory, or clinical research experience is required.
  • Knowledge of ICH Good Clinical Practice (GCP) and clinical study start-up processes is required.
  • Experience coordinating site activation, regulatory submissions, or essential documents is required.
  • Experience coordinating country and site start-up activities against study timelines is required.
  • Experience supporting ethics, regulatory, and site submission activities as applicable is required.
  • Experience identifying start-up risks and following actions through resolution is required.
  • Experience with local ethics committee or regulatory submission requirements in Argentina is required.
  • Experience in clinical research, study start-up, site activation, or regulatory affairs is required.
  • Ability to review protocols and study documents in both Spanish and English is required.

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.
  • Deliver site start-up and activation work to a high standard while working with the team and stakeholders.
  • Facilitate the initiation of clinical trials while ensuring compliance with regulatory requirements.

Desired Qualifications

  • Site contract or budget experience is preferred.
  • Experience with clinical trial management systems (CTMS), electronic Trial Master File (eTMF), or a start-up platform is preferred.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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