Ref #: 31699

Employment type: Permanent - Full-Time

Location: Warsaw, Poland

Posted: 31-Aug-2021


ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

This position will support the G-CTA (Study-facing) in operational aspects of all client managed trials, both internally managed and outsourced trials, with variation across all phases of a trial (planning, start-up, execution, data analysis, reporting and disclosure).
You will work in support of the G-CTA (Study-facing) and Regional G-CTA Team Lead with assigned work to track study timelines and trial budget, to support protocol and country feasibility, site selection, and trial and vendor set-up, study execution and trial closure tracking and reporting related activities.

Responsibilities include generation of progress tracking reports, trial specific system set-up and access management, system data entry, document management and study metrics reporting.

This position will report into a ICON G-CTA Team Lead with dotted line matrix reporting structure with designated G-CTA (Study-facing).

Key Responsibilities: 
• Assist in the preparation of study specific document management, including finalization, distribution, and document revision management and archiving.
• Assist with the current study status and tracking of trial related information is available at all times in the appropriate clinical trial management system(s) (CTMS).
• Work with G-CTA (Study-facing) to ensure trial specific data are up-to-date, complete, and accurate during all phases of the trial.
• Work with G-CTA (Study-facing) to support study coordination activities and tracking of study timelines and study deliverables to ensure trial delivery according to the agreed upon timelines/milestones.
• Assist with review/management of Trial Master File for completeness and timely provision of TMF content.
• Support running GCDO dashboards & metrics reports.
• Support G-CTA (SF) with medication related activities e.g. shipment tracking for non IWRS trial.
• Assist in maintenance of key trial specific information including trial contact lists (TCL) and set-up of study specific training curriculum, and follow up on training completion.
• Support quality oversight and inspection readiness activities.
• Work with G-CTA (Study-facing) to assist in management of tracking country and site feasibility, and requesting and tracking country-specific clinical trial insurance.
• Assist G-CTA (Study-facing) with applicable system support, (i.e., ARIBA, Totality), tracking and analyzing the trial budget, including actual vs. plan trial budget spend as needed.
• Provide overview of data management metrics as requested, including status of data entry/missing pages, source data verification progress, and support query resolutions.
• Other activities as delegated by the G-CTA Team Leader as required

Required experience and qualifications: 
• Bachelor’s degree preferred. However, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
• Experience in clinical trials is required, for example as Study Coordinator or on similar position (at least 6 months)
• Proficient organization skills.
• Excellent written/verbal communication skills (English) and the ability to work independently within a global, virtual team environment.
• Able to demonstrate independent time management skills.
• Able to demonstrate ability to plan and track deliverables and timelines.
• Excellence in providing quality work and being detail oriented.
• Able to demonstrate ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business.
• Excellent utilizing Microsoft Office applications (EXCEL, WORD, PowerPoint, Outlook) and Internet based systems (WebEx, eTMF, SharePoint, etc.).

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

How to apply?
This is an exceptional opportunity within a global organisation who offers rewarding careers. If you want to be a part of this exciting opportunity who offers a competitive salary, excellent benefits package, please contact Dagmara Drozdowska, Recruitment Consultant at DOCS and email your up-to-date CV to: