Disclosure Specialist (Transparency)

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Clinical Data Disclosure & Transparency (CDD&T) Disclosure Specialist 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.

• 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.
•  Attends and assists with CDD&T related meetings
•  Supports 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
• Develops tools to support the tracking of PLS deliverables (including tracking and metrics)
• Collaborates with PLS team in the development and maintenance of plain language structured content and graphics libraries
• Provides support in maintaining the Health Literate Glossary
• Participates in user acceptance testing (UAT) testing, document/data management/clean-up projects, audit preparation and participation when applicable
• Assures management is informed of any problems or unresolved issues that could affect the timely completion of work or the quality of work.
•  Performs other duties as assigned.

• Minimum Bachelor's Degree required; science background preferred
• Minimum 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
•  Excellent communication skills, both oral and written, are mandatory
•  Experience in the use of Doc base system or similar Electronic Document Management system is a plus
•  Health Literacy and Plain Language Summary experience a plus
•  Project management experience preferred
•  International study experience a plus
•  Demonstrated ability to be customer-oriented to achieve high customer satisfaction levels
•  Demonstrated ability to prioritize and manage multiple tasks
•  Ability to attend to detail, think logically and to critically evaluate and solve problems
•  Demonstrated good judgment and independent decision-making abilities, as well as strong follow-up skills
•  Ability to work with multiple study teams in one or more therapeutic areas
•  Computer literacy required

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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.