Senior CTA

As a Senior CTA, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Currently for our Client- Top Pharmaceutical Company, ICON seeks for experienced CTAs with at least two years of experience in this position. This is remote work, but successful candidates must be located no further than 2 hours drive from Warsaw.

Senior Global CTA will be an integral part of the study team by providing administrative and project tracking support to the Global Project Managers and Global Clinical Trial Managers with emphasis on supporting inspection readiness.

RESPONSIBILITIES

• Support operational aspects of managed trials, across all trial phases (planning, start-up, execution, data analysis, reporting and closure).
• Recognize, exemplify and adhere to ICON’s values. Embrace and contribute to ICON’s culture of process improvement with a focus on adding value to our business and meeting client needs.
• Tracking trial related supplies and data including tracking progress towards planned milestones, as well as related progress analysis, and associated follow-up required.
• Tracking the trial and country budgets and support invoice reconciliation.
• Supporting protocol and country feasibility, site selection, and vendor set-up.
• Performing activities related to trial systems, including specific system set-up, access management, data entry, trial level tracking activities.
• Responsible for internal and external meeting planning, coordination, outcome documentation, and related follow up.
• Responsible for Document management.

Deliverables/Services rendered will:

• Adhere to applicable SOPs WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
• Comply with relevant training requirements.
• Assist in trial specific document management, including finalization, distribution, and document revision management and archiving, with a strong focus on inspection readiness.
• Assist in IP and ancillary supply management, including ordering, distribution, and tracking.
• Ensure the current trial status and tracking of trial related information is available at all times in the appropriate Clinical Trial Management System(s) (CTMS) and/or tracking tools. Ensure trial specific data are up-to-date, complete, and accurate during all phases of the trial in collaboration with CRO, Local Trial Managers and Site Managers.
• Ensure trial delivery according to the agreed upon timelines/milestones by conducting supportive trial coordination activities and tracking of trial timelines and deliverables. Run data & metric reports in support of trial deliverables.
• Responsible for review/management of Trial Master File (TMF) for completeness and timely provision
• Maintain key trial specific information, including trial contact list.
• Set-up of trial specific training curriculum and follow up on timely training completion.
• Support activities for quality oversight and inspection readiness.
• Work with internal partners to assist in management of activities such as country and site feasibility and obtaining country-specific clinical trial insurance.
• Work with internal partners, and external vendors including Contract Research Organization/Academic Research Organization for outsourced trials/activities.
• Assist with applicable system support, including tracking of vendor work orders and change orders, tracking and analyzing the trial budget, including actual vs. plan trial budget spend, follow-up on variances, as needed.
• Provide overview of data management metrics as needed, including status of data entry/missing pages, source data verification progress, and query resolution.
• Participate in preparation for and conduct of Health Authority inspections and internal audits.
• Conduct activities to support timely and successful database locks.
• May contribute to process improvement and/or non-project work.

• At least two years of experience as CTA (mandatory)
• Clear and concise written and verbal communication skills.
• proficient in speaking and writing local country language and English.
• Experience in developing presentations and presenting key information to stakeholders.
• Excellent independent time management skills.
• Ability to understand key information to plan and track deliverables and timelines.
• Ability to excel in a dynamic environment and to prioritize and respond to changing needs.
• Advanced skill level in Microsoft Office applications and other systems and technologies skills.
• Ability to quickly learn and work in new technologies.

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, 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.