Ref #: 31272

Employment type: Permanent - Full-Time

Location: Poland

Posted: 18-Aug-2021

Description

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.

POSITION SUMMARY
This position will support the operational aspects of all globally 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 Clinical Trial Manager (CTM) 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 related activities.
Responsibilities include but are not limited to generation of progress tracking reports, analysis and follow-up, trial specific system set-up and access management, system data entry, setting up meetings and maintaining minutes, document management and investigator meeting set-up and coordination.
This position will report into a DOCS Operations Manager or DOCS Functional Manager with dotted line matrix reporting structure with designated trial team members.

JOB FUNCTIONS/ RESPONSIBILITIES
•Assist in study specific document management, including finalization, distribution, and document revision management and archiving.
•Assist in ancillary supply management, including ordering, distribution, and tracking.
•Ensure 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 CRO, Local Trial Managers and CRAs to ensure trial specific data are up-to date, complete, and accurate during all phases of the trial.
•Support study coordination activities and tracking of study timelines and study deliverables to ensure trial delivery according to agreed upon timelines/milestones.
•Responsible for review/management of Trial Master File (TMF) for completeness and timely provision of TMF content across all GCO functions.
•Support running GCO dashboards & metrics reports with option to provide status
analysis.
•Coordinate and participate in internal and external study specific meetings, as
necessary, and document outcomes, actions, and decisions.
•Support medication related activities e.g. shipment tracking for non IWRS trials,
•Coordination of relabelling, recall, product quality compliant, and follow-up.
•Maintain key trial specific information including contact lists and set-up of study
specific training curriculum, and follow up on training completion.
•Support quality oversight and inspection readiness activities.
•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 CTMs with applicable system support, (i.e., ARIBA, Totality), tracking of vendor work orders and change orders, tracking and analysing 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.
•Other activities as delegated by the CTM or PM

EXPERIENCE/ REQUIREMENTS
•At least Bachelor’s degree preferred
•At least 1 year relevant work experience as CTA
•Excellent organization skills
•Excellent written and verbal communication skills.
•Excellent independent time management skills.
•Proven ability to plan and track deliverables and timelines.
•Ability to work well in a dynamic environment and able to prioritize and respond to changing needs of the business.
•Proficient Microsoft Office applications and use of Internet, EXCEL, POWERPOINT, WORD.


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 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 through the form below.

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