Clinical Trial Transparency Associate - 6-month contract

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

You will support the client’s clinical trial transparency processes in compliance with trial transparency laws and requirements and client policies. Responsibilities may include support for registration and results operations, document disclosure operations, data sharing operations, and plain language summary (PLS) operations.

Support with trial transparency processes. Responsibilities may include any of the following:

• Reviews and prepares documents to ensure personal protected information (PPI) is removed
• Works collaboratively with contributing authors and product development teams to identify commercially confidential information (CCI) in documents for public disclosure
• Executes the preparation, quality check and team review of clinical documents for public release including the completion of the justification table for CCI redactions
• Assists with results and registration process tasks as needed
• Supports the integration of acquired clinical trials to ensure that trial information posted on ClinicalTrials.gov and EudraCT can be located in the client’s local data and document systems
• Assists with plain language summary operations as needed
• Provides support in maintaining the Health Literate Glossary

#LI-NR1

Qualifications:

- Experience with transparency, preferably with redaction/anonymization for EU-CTR/CTIS, Health Canada PCRI, Policy 70 or Policy 42

- 3-5 years of experience working in a clinical setting; clinical/regulatory process experience or in a pharmaceutical environment a must

- Knowledge of ICH and GCP guidelines required

- Experience or general understanding of the European Medicines Agency's (EMA) and/or Health Canada publication of clinical information requirements.

- Experience or general understanding of US and EU clinical trial disclosure requirements

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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, 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.

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.