Job Description

OverviewAs a Clinical Trial Transparency Associate you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence.ResponsibilitiesWhat you will be doing:Possesses a working knowledge of FDAAA (Food and Drug Administration Amendments Act of 2007)
and EMA clinical trial Directive 2001/20/EC compliance and client SOPs.
\xef\x82\xb7 Attends and assists with CDD&T related meetings
\xef\x82\xb7 Supports trial transparency processes. Responsibilities may include any of the following:
\xef\x82\xb7 Reviews and prepares documents to ensure personal protected information (PPI) is removed
\xef\x82\xb7 Works collaboratively with contributing authors and product development teams to identify
commercially confidential information (CCI) in documents for public disclosure
\xef\x82\xb7 Executes the preparation, quality check and team review of clinical documents for public release
including the completion of the justification table for CCI redactions
\xef\x82\xb7 Assists with results and registration process tasks as needed
\xef\x82\xb7 Supports the integration of acquired clinical trials to ensure that trial information posted on
ClinicalTrials.gov and EudraCT can be located in the clients local data and document systems
\xef\x82\xb7 Assists with plain language summary operations as needed
\xef\x82\xb7 Develops tools to support the tracking of PLS deliverables (including tracking and metrics)
\xef\x82\xb7 Collaborates with PLS team in the development and maintenance of plain language structured
content and graphics libraries
\xef\x82\xb7 Provides support in maintaining the Health Literate Glossary
\xef\x82\xb7 Participates in user acceptance testing (UAT) testing, document/data management/clean-up
projects, audit preparation and participation when applicable\xef\x82\xb7 Assures management is informed of any problems or unresolved issues that could affect the timely
completion of work or the quality of work.
\xef\x82\xb7 Performs other duties as assigned.QualificationsYou are:Minimum 3-5 years of experience working in a clinical setting; clinical/regulatory process experience
or in a pharmaceutical environment a must
\xef\x82\xb7 Knowledge of ICH and GCP guidelines required
\xef\x82\xb7 Experience or general understanding of the European Medicines Agency's (EMA) and/or Health
Canada publication of clinical information requirements.
\xef\x82\xb7 Experience or general understanding of US and EU clinical trial disclosure requirements
\xef\x82\xb7 Excellent communication skills, both oral and written, are mandatory
\xef\x82\xb7 Experience in the use of Doc base system or similar Electronic Document Management system is a
plus
\xef\x82\xb7 Health Literacy and Plain Language Summary experience a plus
\xef\x82\xb7 Project management experience preferred
\xef\x82\xb7 International study experience a plus
\xef\x82\xb7 Demonstrated ability to be customer-oriented to achieve high customer satisfaction levels
\xef\x82\xb7 Demonstrated ability to prioritize and manage multiple tasks
\xef\x82\xb7 Ability to attend to detail, think logically and to critically evaluate and solve problems
\xef\x82\xb7 Demonstrated good judgment and independent decision-making abilities, as well as strong follow-up
skills
\xef\x82\xb7 Ability to work with multiple study teams in one or more therapeutic areas
\xef\x82\xb7 Computer literacy requiredWhat ICON can offer you:Our success depends on the quality of our people. Thats why weve 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 familys 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 familys 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/benefitsAt 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 weve done to become a more inclusive organisation. Were 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-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles.

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