Associate Clinical Trial Transparency Associate
- United States
- Medical Writing
- ICON Strategic Solutions
- Remote
TA Business Specialist
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
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:
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 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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