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Global drug and device development services

Site Management Associate

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeRemote in Poland

About the Job

Requirements

  • A degree in Life Science.
  • At least 1 year of clinical trial experience within clinical research.
  • Experience working with electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS).
  • Fluent English.
  • Very good comprehension of Microsoft Office tools, including Excel, PowerPoint, Word, and Outlook.
  • Legal right to work in the country where the role is based.

Responsibilities

  • Contribute as a key member of the sponsor's Global Study Team to deliver clinical studies on time, within budget, and to quality expectations, and ensure inspection readiness by overseeing study eTMF completeness.
  • Oversee budgets by managing Task/Change Orders and expenses, tracking updates, checking consistency between systems and agreements, and escalating issues to the Project Manager.
  • Provide country oversight as a primary point of contact, track recruitment progress, data completeness, and compliance, oversee local budgets, protocol deviations, risks, regulatory approvals, and import-license status.
  • Manage vendors and provide CRO oversight as a primary point of contact, oversee study-specific deliverables, and ensure continued monitoring and timely delivery of activities delegated to third parties.
  • Oversee data, including eTMF setup and completeness, conduct periodic reviews, follow up on missing documents, disseminate safety reports, and ensure eTMF documents are complete and quality-verified.
  • Maintain interactions and meetings with internal and external partners.
  • Review key clinical documents, including the Protocol and Informed Consent Forms, and lead development of study plans for assigned studies, such as Monitoring, Vendor Management, Protocol Deviation Management, Risk Management, and Communication Plans.
  • 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 study level.
  • Knowledge of advanced Excel, timelines and budget tracking systems, and clinical trial management systems.

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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