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Clinical Trial Transparency Manager

  1. United States
2023-102439
  1. Medical Writing
  2. ICON Strategic Solutions
  3. Remote

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About the role

As a Clinical Trial TransParency Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

 

The Trial Transparency Manager is in charge of preparing scientific content to be posted on intranet websites (Health Authority, Company) based on source documents, according to defined process, and consistent with other relevant material.  He/she interacts closely with clinical, statistics, regulatory, medical marketing, patents, legal, etc.  He/she may work on studies performed with the same compound in order to develop an expertise, collaborate more effectively with the project team and ensure alignment of disclosure content and format over time, with internal and external standards.   Document or quality projects related to regulatory, company, or industry requirements may also be in scope of responsibilities.  Trial Transparency deliverables will be of high quality and will meet the disclosure requirements of Health Agencies, Industry Associations, and Sanofi transparency commitments.

 


What you will be doing:

For assigned therapeutic area and/or study area/s, works with study and/or project teams, in order to plan, prepare, and release registrations and results on the appropriate website within the required timelines.   Other deliverables as relevant to business area/s are in scope but not limited to:  

-redaction of clinical documents ;

-public mailboxes; 

-selected aspects of lay summary activity or other summaries to be disclosed

-varied activities related to quality of deliverables (quality control, tracking, alignment to current standards)

 


You are:

Team player

-Scientific background (Bac +5, Masters degree, or equivalent professional experience) with training in statistics.

-Several years of successful experience in a clinical development environment: biostatistics, medical writing, regulatory affairs,…

-Project management training and/or direct experience in a fast-paced project environment



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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