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Senior Clinical Associate
3 months ago
About the role
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.Senior Clinical Associate - office base
What will you be doing?
Maintains study documents and utilizes company systems to manage the bioanalytical data in support of clinical/pre-clinical studies. Provides administrative support to project team members in bioanalytical operations and project management.
Works with the project team to ensure that projects are completed in accordance with contract and client expectations:
- Recognize, exemplify, and adhere to ICON's values which center around our culture of accountability, integrity, partnership, collaboration, and excellence in delivery.
- Support the project teams with the set-up, organization, and maintenance of clinical study documentation (e.g., Study Files, CRFs, etc.) and guidelines (as appropriate) including preparation for internal/external audits, final reconciliation and archival.
- Assist in the processing of Data Collection Forms i.e., log in, tracking, quality control as appropriate for the study.
- Share in the responsibility in the quality control audits of clinical study documentation (e.g., Study Files, CRF Files, Monitoring Files, etc.) to ensure study files are always inspection ready.
- Assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as appropriate)
- Run, review, and analyze study reports for accuracy and work with the project teams to ensure updates are completed correctly.
- Assist in coordination of site/ study related payments, if applicable
- Assist in the tracking and distribution of safety reports.
- Assist with, and attend the Project team meetings, and corresponding activities preparation, generation of meeting minutes and agendas.
- To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.
- To assist with the coordination of various status and tracking reports including but not limited to team member tracking and training.
- To be familiar with Indexing of documents with correct attributes and Performing technical QC (wherever required)
- To be familiar with applicable TMF Master Lists and any project specific requirements.
What you need to have?
- Previous experience using computerized information systems and standard application software (Windows, MS Office)
- High working knowledge with MS Word, PowerPoint, Excel and Outlook
- Previous experience maintaining numerous Excel trackers, preferred
- Previous experience building PowerPoint slides, preferred
- Previous experience in scheduling MS TEAMS and WebEx meetings, preferred
- Fluent Czech and advanced English – Writing, Reading, Speaking
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, including subsidiaries, 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.
