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Global drug and device development services

Project Specialist

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

About the Job

Requirements

  • A university degree is required.
  • One to two years of clinical trial experience within clinical research is required.
  • Availability to start within one to two months is required.
  • Experience working with electronic trial master files (eTMF) and clinical trial management systems (CTMS) is required.
  • Fluent English is required.
  • Very good comprehension of Microsoft Office tools, including Excel, PowerPoint, Word, and Outlook, is required.
  • Excellent stakeholder management and oral and written communication skills, as well as strong interpersonal skills, are required.
  • Employment is contingent upon having the legal right to work in the country where the role is based.

Responsibilities

  • Support global project managers as part of a global study team.
  • Oversee budgets, manage task and change orders and expenses, track updates, check consistency between systems and agreements, and escalate issues to the Project Manager.
  • Act as a primary point of contact and track recruitment progress, data completeness and compliance, local budgets, protocol deviations, risks, regulatory approvals, and import license status.
  • Act as a primary point of contact for vendors, oversee study-specific deliverables, and ensure continued monitoring and timely delivery of activities delegated to third parties.
  • Oversee electronic trial master file (eTMF) completeness.
  • Maintain interactions and meetings with internal and external partners.
  • Review key clinical documents, including protocols and informed consent forms, and lead development of study plans for internal and external use in assigned studies.
  • Monitor study conduct and progress, identify and resolve risks and issues, and escalate them as needed.
  • Set up and maintain systems and tracking tools to ensure quality, consistency, and integration of study data; follow up on discrepancies and grant access to new system users.

Desired Qualifications

  • Experience in global project management or supporting global cross-functional teams at the study level is an advantage.
  • Knowledge of advanced Excel, timelines and budget tracking systems, and clinical trial management systems is an asset.

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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