ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Deliverables:
Contributes to the oversight of IDAR data coding activities to ensure adherence to Regulatory Authority and
Industry standards for coding practices and processes:
• Services rendered will adhere to applicable Client's SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
• Executes and promotes adherence to established coding governance activities and principles.
• Contributes to delivery of consistent, accurate and reproducible coding of clinical trial data meeting individual project timelines.
• Knowledge sharing of coding processes and coding encoding systems with cross‐functional, colleagues including clinical trial teams and programming.
• Contributes to resolution of data coding issues. Addresses cross‐functional and crosssectoral coding inquiries.
• Assists with SAE coding reconciliation.
• Identifies and appropriately reports coding tools/systems issues to EBIS and Head, Global Dictionary Management to ensure tools/systems are consistently available for IDAR and applicable external vendor users.
• Provides coding standards information and feedback to IDAR, DM CRO vendor partners and all clinical teams.
• Contributes to thesaurus development and maintenance including dictionary up‐versioning, synonym list maintenance, reclassification of terms and generation of reports within encoding system.
• Understands and utilizes encoding system functionality and tools to investigate system related coding issues.
• Contributes to maintenance of coding process documentation.
• Contributes to innovative ideas to enhance current coding landscape and increase effective coding e.g. by implementing automation
• Exhibits solid problem solving and decision‐making skills with input and support from Head, Global Dictionary Management.
• Contributes to innovative ideas to enhance current coding landscape and increase effective coding
• ADVANCED:
o Influences IDAR and cross‐sector decisions related to coding processes and systems and understands and aligns with long term and cross sector business needs.Understands and utilizes encoding system functionality and tools to investigate system related coding issues. Coordinates with appropriate Support teams to assist in resolution of issues.
o Contributes to thesaurus development and maintenance. Performs dictionary upversioning, synonym approval.
o Exhibits excellent problem solving and decision‐making skills with minimal supervision
o Contributes to, oversees and undertakes maintenance of coding process documentation.
o Coordinates dictionary enhancement requests to MSSO, UMC Uppsala
o Actively identifies opportunities and solutions to increase efficiency and quality of coding and dictionary management.
Requirements:
- BS health related degree or professional experience equivalent is required.
- In‐depth knowledge of industry standard coding thesauri (MedDRA, WHO Drug) and the ability to utilize and maintain incumbent dictionary encoding products and systems.
- A thorough understanding of clinical research processes and regulations.
- A minimum of 5 years thesaurus management experience is essential.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
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, colour, 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 or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
