Senior CTA

Senior CTA

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.

This role involves supporting the execution of clinical trials by managing administrative tasks and monitoring trial progress. The position is responsible for coordinating and tracking all study documentation, including regulatory materials, study drug information, and clinical trial payments.

​What you will be doing?

• Provide project-specific support and assist with overall clinical trial management in the Clinical Operations Department.

• Organize and coordinate study management team meetings, sponsor and site vendor teleconferences, including preparing and distributing meeting agendas and minutes.

• Assist with the planning and logistics of formal meetings, such as investigator meetings.

• Help develop and write Standard Operating Procedures (SOPs) for the Clinical Operations Department.

• Maintain central files, ensuring version control and quality checks for submitted study documents, reviewing site regulatory documentation for completeness, tracking important dates, and preparing files for audits.

• Track essential documents to ensure they are received and filed in the Trial Master File (TMF); review site documents for accuracy and support the clinical team with TMF management.

• Order and manage ancillary clinical study supplies necessary for conducting trials, including copying, printing study documents, preparing reference binders, and coordinating shipping and tracking.

• Assist in preparing and maintaining Clinical Study Agreements and Confidentiality Agreements.

• Process vendor invoices and initiate requests for investigator, site, and vendor payments.

• Enter and maintain study information in the Clinical Trial Management System (CTMS).

• May take on co-monitoring responsibilities, with potential local and occasional travel.

• Coordinate the review and setup of legal contracts, leases, purchase orders, and other agreements, communicating attorney feedback to internal stakeholders as needed.

• Maintain a Contracts database and physical files for customer contracts and subcontractor agreements.

• Monitor contract status and keep internal stakeholders informed about renewals, rate adjustments, discounts related to revenue milestones, and other contractual obligations.

• Facilitate the review of RFP/Bid contract documents by company attorneys and internal stakeholders to identify potential issues with language or commercial terms.

• Manage the approval, execution, and distribution of contracts, amendments, and extensions.

• Act as a liaison between the company, subcontractors, and all parties involved in contractual agreements

• Contract Management: Support the contracts manager by:

  • Assisting with processing contracts and other documents to ensure timely approval and signatures according to company policies.

  • Collaborating with stakeholders across the company, tracking approval progress, and following up as needed.

  • Supporting site payment reconciliation activities as required.

• Assist with vendor oversight and management, promptly identifying issues and escalating them to management as appropriate.

• Conduct critical reviews and reconciliations of essential documents in the TMF, managing TMF filing and management tasks independently.

• Ensure timely completion of study tasks and update trial trackers continuously.

• Audit the TMF.

Your Profile:

• Bachelor’s degree preferred, ideally in a healthcare or scientific discipline.

• Experience in clinical research or a related field within pharmaceuticals, biotechnology, CROs, or healthcare settings.

• Strong attention to detail and excellent organizational skills.

• Effective interpersonal and communication skills (both written and oral) for working in a team or matrix environment.

• Proficient in verbal and written communication, with strong presentation skills.

• Experience with Office 365 (Word, Excel, PowerPoint) and SharePoint.

• Familiarity with IXRS and EDC systems is a plus.

• Knowledge of clinical research operations, FDA regulations, ICH guidelines, and GCPs governing clinical trials.

• Ability to prioritize multiple tasks, plan proactively, and achieve goals using well-defined instructions and procedures.

• Capability to develop tools and processes that enhance project efficiency.

• Experience in gene therapy and/or rare disease indications is 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