Job Title: Clinical Data Standards Architect
About the Role
We are seeking a highly skilled and experienced Clinical Data Standards Architect to join our team. As a key member of our global team, you will play a vital role in streamlining clinical data processes across therapeutic areas.
Key Responsibilities
* Develop and implement standard metadata to support the full data lifecycle from initial collection to final submission
* Configure standards for specific therapeutic or disease areas to enable optimal reuse and adoption across the R&D portfolio
* Collaborate with cross-functional teams to ensure the correct configuration and adoption of clinical data standards
* Ensure compliance with industry standards (e.g. CDISC) and health authority regulations
Required Skills and Qualifications
To be successful in this role, you will require:
* Bachelor's degree in Life Sciences, Computer Sciences, or equivalent experience
* Minimum 2 years' relevant operational experience in clinical data management or data standards
* Strong expertise in Rave eDC (Medidata Solutions)
* Experience with SAS programming; coding skills preferred
* In-depth understanding of CDISC standards: SDTM, CDASH, define.xml, and Controlled Terminology
Benefits
We offer a range of benefits to support your well-being and work-life balance, including:
* Variety of annual leave entitlements
* Range of health insurance offerings
* Competitive retirement planning options
* Global Employee Assistance Programme
Why Join Us?
We are committed to creating an inclusive and accessible environment for all candidates. Our company values diversity and believes that everyone deserves equal opportunities. If you need reasonable accommodations during the application process, please let us know.