Senior Clinical Trial Transparency Associate

Senior Clinical Trial Transparency Associate 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 client 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)

Team player

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

- Experience with clinical trial transparency  and experience with Policy 0700, Health Canada PRCI, and EU CTIS submissions

-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

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.