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.
- Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements,
- Provides expertise in planning, creation and oversight of clinical programming activities and deliverables from study set-up to submission ready CDISC SDTM tabulation packages (aCRF, define.xml, cSDRG, etc.).
- Review and provide input into all trial set-up documentation.
- Responsible for review or creation of aCRF, DTA metadata and trial design specifications.
- Create or review mapping specifications for internal data and/or SDTM
- Generate or review internal data and/or SDTM datasets using internal conversion framework, utilities, and global checks Ensure quality review of all datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc.) and compliant for interim and final database
- Program, or oversee programming of, quality review checks and reports for use by Data Managers and other team
- Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory
- Responsible for acquiring and maintaining working knowledge in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave, Clinical Data Tools such as LSAF, Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and xml.
- Support the development of standards and drive their implementation within the organization.
- Clinical programming experience and experience working on a clinical
- Bachelor’s degree or higher and/or equivalent in computer science, data science/data engineering, mathematics, or another relevant scientific field (or equivalent theoretical/technical depth).
- Expert knowledge of SAS programming, Define.xml, SDTM aCRF, cSDRGs.
- Expert knowledge of data structures (e.g., CDISC SDTM, ADaM) and their implementation.
- Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
- Project management skills.
- Highly organized with excellent written and verbal communication.
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.
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