Job Details
Clinical Data Standards Architect
5957
Posted: 18/09/2025
- £Competitive
- Home Based , United Kingdom
- Permanent
Clinical Data Standards Architect | Home-based – UK / Europe |
We are seeking an experienced Clinical Data Standards Architect (CDSA) with a strong background in SDTM and Rave Database Build (Rave build is essential). This role sits within a Leading Pharma and focuses on implementing and maintaining clinical data standards that support efficient data collection and delivery throughout the drug development lifecycle.
The CDSA plays a pivotal role in ensuring consistency, compliance, and efficiency by configuring standards to the specific needs of therapeutic areas or compounds, while collaborating closely with clinical data collection teams.
What you will be doing:
What you need:
What’s in it for you:
What to do next:
If this opportunity aligns with your experience and career goals, please apply now with your CV.
Not the right fit?
For a confidential discussion about alternative opportunities, please contact Jo Fornaciari on +44 7488 822 859
We are seeking an experienced Clinical Data Standards Architect (CDSA) with a strong background in SDTM and Rave Database Build (Rave build is essential). This role sits within a Leading Pharma and focuses on implementing and maintaining clinical data standards that support efficient data collection and delivery throughout the drug development lifecycle.
The CDSA plays a pivotal role in ensuring consistency, compliance, and efficiency by configuring standards to the specific needs of therapeutic areas or compounds, while collaborating closely with clinical data collection teams.
What you will be doing:
- Implement and maintain standard content in data collection and delivery tools to drive consistency and efficiency across trials.
- Configure and optimize Rave eDC standards (Medidata Solutions), including Standard CRF mockups, Standard validation rule specifications, Standard questionnaires, rating scales, and COAs, Standard integrations (e.g., IWRS).
- Define, annotate, and maintain data delivery standards, including Study Data Tabulation Model (SDTM), Annotated CRFs, Data transfer agreement (DTA) standards linked to SDTM and Mapping metadata (CRF/DTA → DRM, DRM → SDTM).
- Collaborate with cross-functional teams (data management, clinical analysis, IDAR, technical architects) to ensure accurate testing, QC, and validation of collection tools and metadata.
- Maintain and govern master standards, applying formal change management control and versioning.
- Pre-configure standards in line with lifecycle data plans while ensuring traceability and data lineage.
- Provide support and guidance for consistent adoption of standards in clinical studies.
What you need:
- Proven expertise in Rave eDC (Medidata Solutions) – database build experience is mandatory.
- Strong knowledge and hands-on experience with CDISC standards (SDTM, CDASH, controlled terminology, define.xml).
- Experience in clinical data management and/or standards.
- Excellent communication skills both written & verbal, English.
- SAS programming experience, with ability to run and/or code programs.
- Familiarity with SAS LSAF and Pinnacle 21.
- Knowledge of annotated CRFs and regulatory submission requirements.
- BS/BA degree in life sciences, computer science, or equivalent experience.
What’s in it for you:
- Opportunity to work fully remotely across the UK or Europe.
- Partner with a leading global pharmaceutical company through a global CRO.
- Play a key role in shaping clinical data standards that directly support global drug development.
What to do next:
If this opportunity aligns with your experience and career goals, please apply now with your CV.
Not the right fit?
For a confidential discussion about alternative opportunities, please contact Jo Fornaciari on +44 7488 822 859
Jo Fornaciari
Principal Consultant in Statistical Programming
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