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Global drug and device development services

Associate Clinical System Designer

Clinical Research OperationsPosted on Nov 10
Full-timeNo salary listed

About the Job

Requirements

  • At least 6 months of experience designing and implementing clinical systems within the clinical research industry.
  • Expertise in data analysis and interpretation or database development, with proficiency in clinical data management systems and software.
  • Experience with Medidata Rave and/or Veeva EDC.
  • Functional knowledge of CRF design tools and the ability to plan and design CDMS components directly from the interpretation of medium-complexity clinical trial protocols.
  • A Bachelor’s Degree in a relevant field.
  • Applications must be submitted in English.
  • Applicants must have the legal right to work in the country where the role is based.

Responsibilities

  • Assist with developing custom CRF screens, edit check, and dynamic check specification documents, using prototyping methodologies as needed.
  • Assist with creating technical specifications for output programming, including data validation outputs, data analytics outputs, and custom output programs.
  • Copy and modify CRFs from standard libraries and other studies under specific instruction.
  • Read, understand, and adhere to the study protocol, contract, and scope of work for all tasks during study set-up, maintenance, and close-out.
  • Track and keep functional management and project management stakeholders informed of issues that might affect project target dates, scope, or budget; escalate potential problems effectively and in a timely manner.
  • With support, consolidate and complete high-level system requirements documents and facilitate their review.
  • With support, perform quality-control peer reviews of database-related specifications as needed and record comments appropriately.
  • Support more senior project leads in eCRF and other specification review meetings.
  • Support simple-to-medium migration and post-production change activities.
  • Assist with EDC integration-related activities.

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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