Senior Clinical Trial Associate

FSP-(Senior) Clinical Trial Associate-Client Office Based with Flexible Work From Home

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Senior Clinical Trial Associate at ICON Plc, you will support the management and execution of clinical trials by handling a range of administrative and operational tasks.

What You Will Do:

Prepare / submit clinical trial application dossier according to the given instruction from the responsible CSM / responsible CRAs while fully GCP, ICH, local regulations and Global Pharma SOP complaint and maintain in-house TMF submission documents properly.

Key responsibilities include:

• Prepare the EC/IRB submission for new / ongoing clinical trials
• Translate the global English study documents/tools(e.g. Informed consent
• Follow up the EC review status of assigned projects
• Coordinate the response to EC queries and ensure the reply is timely submitted to EC
• Setup and maintain the submission dossiers
• Serve as CTA hub contact to upload local documents for HA submission to REDI_AA and submit the completed dossier to HA
• May serve as a backup for IMP CPO contact defined in local SOP in term of clinical trial supplies management according to the assignment
• Align with CRAs/CSMs to generate the start up plan milestone dates and ensure that study milestones are met as planned (i.e. submission & approval date, startup, recruitment, closeout, etc).

Your Profile:

You will have a strong foundation in clinical trial management, with the experience to work independently and guide others.

Required qualifications and experience:

• Demonstrate ability to coordinate, organize and communicate
• Basic understanding of clinical development process including GCP and ICH fundamentals
• Proven ability to work on teams and deliver on commitment
• At least two years IRB amendment experience, nice to have initial submission experience.
• Strong Team work and internal influence
• Basic Therapeutic area knowledge.
• Communication with EC/HA

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply