Principal Clinical Data Standards Consultant

hace 3 semanas

Madrid, España Icon Plc A tiempo completo

Principal Clinical Data Standards Consultant - EMEA 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.
We are currently seeking a Principal Clinical Data Standards Consultant to join our diverse and dynamic team.
As a Clinical Data Standards Consultant at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
We are happy to support applications from across EMEA.
What you will be doing: Developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards.
Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials.
Developing and maintaining training and reference materials related to standards topics including CDASH, SDTM, Terminology, ADaM, define-XML and regulatory submission requirements.
Managing the development and maintenance of data management processes and tools.
Keeping abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices.
Your profile: A Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science, or related discipline); advanced degrees are a plus.
Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry.
Advanced proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e.g., FDA, EMA).
Excellent analytical and problem-solving skills with a keen attention to detail.
Excellent communication and collaboration abilities to work effectively in cross-functional teams.
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 focused on well-being and work-life balance opportunities for you and your family.
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 maximize 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 specialized 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.
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 organization.
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.
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