Senior Clinical Trial Transparency Associate

2 weeks ago


Sydney, New South Wales, Australia ICON Full time
Overview

As a Clinical Trial Transparency Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

In this role you will oversee and coordinate redaction activities across multiple delivery units, Familiarity with clinical trial and submission documents is required.

What you will be doing:
  • Coordinates operational aspects of transparency activities such as, collecting content that will need to be redacted/anonymized from identified PoCs, partner with anonymization provider in getting content anonymized, issue and release of anonymized content.
  • Understand general principles of redaction and protection of personal information.
  • Ensures data transparency deliverables are tracked and/or published using appropriate systems/tools.
  • Applies appropriate data transparency standards, requirements, processes, and policies to comply with applicable health agency requirements.
  • Provides document management services, including management of documents in the submissions document repository, indexing, and archiving of approved documents in accordance with quality standards.

You are:

  • Experience with redaction and protection of personal information in scientific field (pharma , CRO, other) required
  • Clinical document specialist / scientidfic writing support experience would be a good fit
  • 1-3 years of experience in clinical trial management, regulatory submissions, or publishing is preferred.
  • Basic understanding of clinical trial or submission document disclosure requirements.
  • Knowledge of electronic document management systems and proficiency using Adobe Acrobat.
  • Proficiency in disclosure-related Health Authority and industry regulations and guidelines (ie, EU CTR, PRCI, CDP (Policy 70)
What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family's needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.


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