Sharp Packaging Solutions, part of UDG Healthcare plc
IRT Data Coordinator
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Summary
The IRT Data Coordinator will assist with project support, data reconciliation, and administration for study-related projects by utilizing IRT (Interactive Response Technologies) software. Assist with project support and administration for projects by performing essential duties and responsibilities.
Essential Duties and Responsibilities
- Work closely with IRT Project Managers on assigned study support tasks to meet project deliverables and milestones within the various stages of the project life cycle.
- Serve as an additional point of contact to sponsors, sponsor vendors, and sites.
- Resolve or escalate study support issues in accordance with processes, work instructions, and standard operating procedures (SOP).
- Develop project-specific import/export and report specifications.
- Assist with the set-up of client acceptance testing (CAT).
- Collect, document, and perform requested parameter and data changes in alignment with documented procedures.
- Create, revise, and maintain study-specific documents such as user guides.
- Collaborate with internal teams and sponsors to create and maintain study-specific training materials.
- Monitor study-specific IRT issues and resolutions for trends.
- Provide urgent study-specific support after normal business hours as needed.
- Perform other duties as assigned.
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Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Associate’s degree required, Bachelor’s preferred
- 1+ year of exposure to clinical trials
- Previous experience with clinical trials in a client-facing role is strongly preferred
- Basic understanding of medical and/or clinical trial terminology
- Experience working with computer software including Word, Excel, and Access preferred
- Ability to work independently and adjust to changing priorities
- Excellent attention to detail and orientation toward project work
- Strong verbal and written communication skills
About Sharp Packaging Services
Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together, our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium, and the Netherlands.
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We’ve built an exceptional global reputation for the design, serialization, and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches, and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture, and delivery.
Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing, and comparator sourcing.
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