Ref #: 29682

Employment type: Permanent - Full-Time

Location: Warsaw, Poland

Posted: 04-Jun-2021


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 DOCS 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
• 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.).

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 Dariusz Sternlicht, Recruitment Consultant at DOCS and email your up-to-date CV to:

Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.

It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.

At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.