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Global drug and device development services

Central Review Coordinator

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

About the Job

Requirements

  • A Bachelor of Science degree in Life Science and solid experience working within a contract research organization and/or the pharmaceutical industry.
  • A genuine interest in using clinical experience to develop a career in clinical data.
  • Strong experience with at least one data management system, such as Rave.
  • Experience in most study tasks.
  • Comfort working within a project team.
  • Experience using Microsoft Word and Excel.
  • Strong attention to detail.
  • Effective time management and prioritization skills.

Responsibilities

  • Create and maintain study trackers.
  • Monitor screening deadlines; follow up with sites on data entry and other vendor data entry; and escalate visits that are not released for central review or queries that are not addressed within timelines.
  • Review and determine whether study visits and sweeps are ready for review using page status and query reports.
  • Create, send, and process assignments to reviewers, including query tracking.
  • Download and compile files for patient profile creation and post them on the Central Grading Portal for the Data Programmer, CRS.
  • Create internal CRS agendas and meeting minutes for distribution.
  • Update and maintain the action/decision log.
  • File documents in the Central Grading Portal and electronic Trial Master File (eTMF).
  • Liaise with directors, therapeutic experts, internal team members, and sponsors.
  • Perform proficient reviews of study datasets prior to client transfer, if applicable.
  • Monitor review progress to meet timelines, identify issues, risks, and possible solutions, and report them to the Lead Central Review Manager.
  • Participate in database lock activities.
  • Serve as Central Review Coordinator on one or more projects.

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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