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Global drug and device development services

Clinical Data Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A bachelor's degree in a life-sciences-related discipline is required.
  • At least five years of clinical data management experience in a CRO, pharmaceutical, or biotechnology environment is required.
  • Experience leading or co-leading studies from start-up through database lock and close-out is required.
  • Hands-on experience with electronic data capture review, data cleaning, query management, external data reconciliation, and user acceptance testing is required.
  • Clear communication skills and the ability to work independently within fast-paced global study teams are required.

Responsibilities

  • Lead or co-lead data management activities across assigned studies from start-up through close-out.
  • Perform electronic data capture review, data cleaning, query management, and reconciliation of external data sources.
  • Create and maintain study documentation, including Data Management Plans, Data Review Plans, electronic case report form Completion Guidelines, and Edit Check Specifications.
  • Conduct electronic data capture and data-validation-listing user acceptance testing and support database-lock readiness.
  • Partner with study teams and vendors to resolve data issues, including discrepancies involving electronic clinical outcome assessment, pharmacokinetic, biomarker, local laboratory, and safety data.
  • Support serious adverse event and protocol-deviation reconciliation, issue-log maintenance, metrics reporting, and electronic trial master file filing.

Desired Qualifications

  • Veeva electronic data capture experience is desirable but not essential.

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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