Ref #: 32633

Employment type: Permanent - Full-Time

Location: Warsaw, Poland

Posted: 29-Sep-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.

The role:
*Processes and reviews the CRF, third party data, and local laboratory data, if applicable.
*Supports and leads the clinical data review activities associated with a clinical trial.
*Prepares and completes quality control reviews and delivers the end product of clinical data that meets agreed upon data integrity standards
*Serves as lead clinical data coordinator for one or more projects.
*Reviews clinical and external data for subjects enrolled in clinical research protocols based on edit specifications / data validation programs to facilitate data review.
*Maintains Data Management Plan (including CRF related components) as appropriate.
*May be responsible for data entry activities, quality control reviews, identification and documentation of data problems during CRF tracking, Casebook Manager set-up and maintenance and serve as primary contact for data entry activities for functional management and internal study team members.
*Performs proficient reviews of study datasets prior to client transfer.
*Manages the data review and external data reconciliation process.
*Utilizes internal systems to optimize and communicate resourcing issues and needs.
*Ensures study and task metrics are tracked and communicated to the project team and functional management.
*May participate in sponsor and/or third party audits


To be successful in the role, you will have:
*Bachelor’s/MA degree
*A minimum of 6 months of clinical data management experience.
*Fluent English

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.