Clinical Trial Transparency Associate

As a Clinical Trial Transparency Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This is a short term 6 month fixed-term position.

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

For additional information and to apply for this job, click here.