As a Principal Clinical Data Standards you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
- Generate clinical data standard metadata that adheres to regulatory authority requirements
- Create templates for documenting clinical data standards, such as non-CRF standard data transfers (e.g., lab or ECG), to ensure consistent clinical data standards with external data vendors
- Maintain lists of controlled terminology, lab tests and other standardized terms to ensure consistency with the latest guidelines
- Attend governance committee meetings and document discussion and decisions
- Keep track of action items and upcoming topics for discussion; research topics for discussion and provide background to the governance committees
- Coach CROs and vendors on data standards and related processes
- Communicate and reinforce content and interpretation of data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project
You are:
-10 + years of experience
- Strong understanding of industry clinical standards such as CDISC CDASH, SDTM, ADaM; and, controlled terminology, HL7 and ICH
- Ability to translate complex data concepts into concrete examples of how to implement data standards into actionable study processes
- Experience with managing global data standards, including creating data standards, training others on the use of data standards and validating that standards are implemented correctly
- Effectively communicate with technical and non-technical stakeholders
- Strong Microsoft Office skills, including Excel, PowerPoint and Word
- Database skills such as MySQL, Oracle or PostgreSQL
- Work with standards management systems and software, such as MDR, Change Request systems, SDTM validation systems, and issues tracking systems
- Experience with Medidata Rave (EDC) is preferred
- Strong working knowledge of the overall pharmaceutical development process
- Strong working knowledge of SDTM and the creation of data mapping specifications and annotated CRFs.
- Knowledge of requirements of define.xml
- Experience in CRF design, query resolution, and general data validation
- Strong communication skills, including ability to communicate standards related issues, options, and their impact to project teams and within department
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
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.
https://careers.iconplc.com/reasonable-accommodations
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.
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