Ref #: 30916

Employment type: Permanent - Full-Time

Location: Poland

Posted: 23-Jul-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.

To provide timely and professional ongoing management of Data Management deliverables and of clinical trial data with respect to cost, quality and timelines for all assigned trials within Clinical Data Management. Ensure consistently high quality data available for analysis and reporting..

*Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager where needed
*Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes.
*Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards
*Performs DM activities for start up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP), Data Review *Plan (DRP) and performing user acceptance testing (UAT)
*Manage local lab set up for the Clinical Database as applicable
*Performs DM hands on activities during the course of the study
*Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
*Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation
*Supports and assists Junior staff for assigned trials
*Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner
*Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
*Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).
*Ensures adherence to GCP, DM standards, SOPs/WPS and process guidelines

*University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
*Ideally 4 years’ experience in Drug Development with at least 3 years' in Clinical Data Management (experience as Lead Data Manager is an asset)
*Languages: Fluent English (oral and written).
*Ability to work under pressure demonstrating agility through effective and innovative team leadership
*Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders
*Excellent problem solving skills
*Excellent verbal and written skills

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.