Ref #: 30594

Employment type: Permanent - Full-Time

Location: Warsaw, Poland

Posted: 09-Jul-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.
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.

CTA performs administrative tasks to support the CDC trial teams (Trial Managers and Clinical Research Associates) for assigned clinical trials in accordance with the Sponsor's policies and procedures, SOP’s, local legislation and GCP requirements. The position is based in Warsaw, Poland and reports to CTA Team Manager, CDC Poland.

Essential responsibilities
•Oversight of all trial documentation for assigned clinical trial, covering all involved adjacent affiliates within the CDC:
- CTA documentation to support affiliates in HA and EC submissions,
- Ensure overview of local requirements.
•Oversight of the documents filed into the eTMF: technical quality review and quality control of documents. Timely eTMF handling and archiving.
•Timely updating of relevant trial logs in the system.
•Timely completeness check of trial documentation in the system.
•Ensure timely and adequate archiving at closeout.
•Providing Investigator Trial Master Files (ITMFs) core input and additional patient material during a course of study.
•Supporting in bulk document distribution to sites.
•Updating data in CTMS (RDA role).
•Supporting clinical supplies management and tracking all relevant processes.
•Other administrative tasks as relevant (incl. payments, management of mailing lists, generic mailboxes, support in organisation of local meetings and department meetings).

Qualifications
•Preferably Master/Bachelor degree in life sciences
•Very good English – written and spoken
•At least one year on the similar position as CTA
•Excellent organization and long-term planning skills
•Ability to work independently in a structured and pro-active manner as well as part of the different trial teams
•Ability to manage multiple priorities
•Keeping focus on details and at the same time maintain overview and quality
•Cross-cultural awareness and ability to cooperate in multi-national environment
•Very good communication skills - ability to communicate and build relationships with various stakeholders
•IT proficiency (including MS Office: Outlook, Excel, Word, PowerPoint)
•Knowledge of eTMF systems, such as Veeva Vault is considered an advantage

Benefits of working in ICON
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.
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.

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