Associate Clinical Trial Transparency Associate

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.

What you will be doing:

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.

You are:

• Minimum of Bachelor's degree
• 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

Why 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.

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.

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, 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.

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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