Clinical Trial Transparency Associate

Clinical Trial Transparency Associate

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

ICON is seeking a highly skilled Clinical Trial Transparency Associate. The ideal candidate will possess strong proficiency in drafting results disclosures tailored for platforms such as ClinicalTrials.gov and EudraCT/CTIS and a demonstrated track record in crafting clear and concise Plain Language Summaries (PLS) that adhere to industry standards and best practices. With a preferred 2-year experience in transparency including understanding of both U.S. and EMA regulations, including U.S. Public Law 110-85 (FDAAA 801) and Regulation (EU) CTR 536/2014. Familiarity in Health Canada PRCI and EMA Policy 0070 considered advantageous.

As a member of the ICON team, you will assume a critical role in ensuring transparency and compliance in the dissemination of clinical trial information to a diverse array of stakeholders.

Specific responsibilities include:

• Independently managing, creating, and providing operational support, for any of the below CTT deliverables:

  • Clinical trial disclosure to global registries (including but not limited to ClinicalTrials.gov and EudraCT/CTIS), such as protocol registrations, protocol amendments, maintenance and results postings

  • Plain Language writing experience

  • Redaction and anonymization of clinical documents

• Performing quality control review of above CTT deliverables where applicable

• Communicating with appropriate key internal and external stakeholders to ensure deliverables are completed to client standards and within agreed upon timelines

• Remaining current with changes in regulatory requirements regarding clinical trial transparency

• Consulting with health authorities to resolve submission queries

• Independently managing and executing assignments, making effective/appropriate decisions regarding competing priorities​

• Participating in meetings/workshops or client meetings/functions as needed.

• Reviewing and improving job aids, work instructions, and user guides, as needed

Benefits of Working in ICON:

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

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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.

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