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Global drug and device development services

Manager of Study Start Up

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeRemote in USANo salary listed

About the Job

Requirements

  • A bachelor's degree in a relevant scientific discipline or healthcare-related field is required.
  • Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations.
  • Experience managing and mentoring teams in a fast-paced, deadline-driven environment.
  • Organizational and project management skills, including the ability to handle multiple studies and priorities simultaneously.
  • Communication and stakeholder management skills, including effective collaboration with sponsors and internal teams.
  • Experience with process optimization and implementing best practices in study start-up activities.
  • Willingness to travel as required, approximately 25%.

Responsibilities

  • Manage and oversee the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation.
  • Lead a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery.
  • Collaborate with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation.
  • Monitor study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope.
  • Identify potential risks and challenges in the start-up process and implement strategies to mitigate delays or issues.
  • Drive continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency.

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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