Global Study Associate

Global Studies 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.

What you will be doing

• Support Global Study Director (GSD) / Global Study Associate Director (GSAD) and Global Study Managers (GSMs) by completing delegated study work.

• Initiate and lead the set-up of the electronic Trial Master File (eTMF). Maintain and close the eTMF to ensure compliance to International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs.

• Collaborate with Site Management & Monitoring, extended study team and external vendors in collection of regulatory and other essential documents.

• Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection

• Contribute to electronic applications/submissions by creating and managing clinical- regulatory documents according to the requested technical standards and supporting effective publishing and delivery to regulatory Proactively plan and collate the administrative appendices for the CSR.

• Initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements.

• Set-up, populate and accurately maintain information in tracking and communication tools and support team members in the usage of these tools.

• Support the set-up, maintenance and close-out of Clinical Trial Transparency (CTT) activity in PharmaCM, coordinating with relevant stakeholders to fulfil AstraZeneca compliance and meet the regulatory authority needs.

• Support the GSD/GSAD with tracking, reconciliation and follow-up of the study budget/ payments in relevant systems

• Contribute to application, coordination, supply and tracking of study materials and Contribute to collection of study supplies, if required, at the study close-out.

• Coordinate administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs

• Lead the practical arrangements coordination and contribute to the preparation of internal and external meetings g. study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. Liaise with internal and external participants and/or vendors.

Your profile

• Education in in medical or biological sciences or discipline associated with clinical research preferred

• Proven organizational and analytical

• Previous administrative training/experience.

• Computer proficiency in day-to-day

• Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines.

• Excellent verbal and written communication in English.

• Demonstrate ability to work independently, as well as in a team environment.

• Willingness and ability to train others on study administration procedures.

• Global study support experience preferred but not required

• Experience managing eTMF and CTMS systems is required (Veeva Vault experience preferred)

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