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Clinical Study Associate

Clinical Study Associate

ICONRemote, US
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Clinical Study Associate

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.

We are currently seeking a Clinical Associate to join our diverse and dynamic team as an FSP member of staff, working as a Clinical Study Associate, dedicated exclusively to a Pharmaceutical Company. The Clinical Study Associate will perform tasks related to the planning and execution of clinical studies within Global Clinical Development Operations.

What you will be doing

The Clinical Study Associate will provide support for critical day to day clinical study activities, including regulatory inspection readiness, in accordance with established protocols, under the supervision of the CSA Manager. They will collaborate with CSA colleagues, study teams and Clinical Research Organisations to support clinical study activities as defined by the operating model.

For this role, candidates should be familiar with Veeva Vault (CDMS and CTMS) and have a proven ability to manage meeting agendas and minutes. They must also demonstrate proficiency in maintaining study team rosters, understanding the importance of TMF quality control for inspection readiness, and effectively monitoring site reports while addressing concerns with the Clinical Study Manager. Additionally, experience in maintaining an organized list of Standard Operating Procedures (SOPs) is essential.

Vendor budget / invoice tracking will also be a key activity. Candidates should be able to demonstrate familiarity with systems to check patient enrollment, timelines and running metrics reports. They will also work with the Sponsor Clinical Study Associate on the Study Team Training matrix.

Your profile

The ideal candidate should possess experience in proactive strategic thinking, effectively anticipating next steps and providing necessary support. They must be a self-starter who can work independently with minimal supervision while exhibiting strong collaboration skills and clear communication to ensure timely execution of tasks.

  • Bachelor's degree in Life Sciences, Health Sciences, or a related field.
  • 1-2 years' experience in pharmaceutical industry, clinical research organization, or related role.
  • Experience in Phase 2 and 3 Studies and global / international studies is advantageous.
  • Experience working across multiple therapeutic areas (including oncology) is advantageous.
  • Knowledge in global / regional regulatory and compliance requirements for clinical research
  • Demonstrated excellence in task management and cross-functional collaboration.
  • Excellent communication skills.
  • Excellent teamwork, organizational, interpersonal and problem solving skills.
  • Fluent business English (oral and written)

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

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