I

Icon

Global drug and device development services

Principal Clinical Data & EDC Programmer

Clinical Research OperationsUpdated on Nov 5
Full-timeRemote

About the Job

Requirements

  • At least 10 years of experience with EDC programming using Medidata Rave and/or Veeva, including data validation outputs, data review and risk management outputs, custom reports, and clinical-trial programs.
  • Proficiency with SQL and/or SAS programming for vendor data imports or creating data management reconciliation outputs.
  • Experience leading studies, providing training, and mentoring junior programmers.
  • Strong problem-solving skills and the ability to work collaboratively in a fast-paced, cross-functional environment.
  • Excellent attention to detail and organizational skills, with a commitment to delivering high-quality results.
  • A bachelor's degree in a relevant field.

Responsibilities

  • Develop, validate, and maintain programming solutions for clinical data management systems, including EDC systems such as Rave and Veeva, data validation outputs, data review and risk management outputs, custom reports, and clinical-trial programs, using SAS, R, and/or Python.
  • Develop and maintain programs for handling external vendor data using SAS, R, and/or SQL.
  • Extract data from clinical data management systems and create data transfer programs.
  • Collaborate with data managers, project managers, biostatisticians, and others to integrate programming solutions into the overall data management process.
  • Serve as a primary point of contact for study teams on system programming questions during study setup and maintenance.
  • Participate in internal and external meetings and provide constructive feedback to peers, team leads, and functional management.
  • Mentor and provide ad hoc guidance, training, and support to other programmers.
  • Share knowledge within the Programmers group through presentations and preparation of training materials.
  • Assist in developing and implementing improvements to technical systems and processes as a subject-matter expert.
  • Stay current with programming languages and data management tools to improve operational efficiency.
  • Provide final-level technical review and consultation for complex programming activities.
  • Provide technical leadership for cross-study and program-level analytics initiatives.
  • Lead implementation of analytical techniques, automation strategies, and process improvements.

Desired Qualifications

  • Experience with bid defense meetings.
  • Experience programming with R and Python.

About the Company

Icon

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

Recently Posted Jobs

Explore more opportunities at Icon

See more jobs