• Data Collection Standards Architect (Homebased - UK)

IQVIA; Reading; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading global provider of clinical research services is seeking a Clinical Data Standards Architect in Reading, UK. This role involves implementing standards in data collection and delivery tools, along with maintaining clinical data standards. The ideal candidate will have deep expertise in Rave EDC and knowledge of CDISC standards, with strong communication skills. This position is not eligible for UK visa sponsorship.

Qualifications

• Deep expertise in Rave EDC (Medidata Solutions).
• Experience with SAS programming; coding experience preferred.
• At least 2 years of relevant operational experience in clinical data management or standards.

Responsibilities

• Implements standard content in data collection and delivery tools.
• Responsible for testing and QC of collection tools.
• Defines and maintains standard clinical data collection standards.

Skills

Expertise in Rave EDC

SAS programming

Knowledge of CDISC standards

Excellent communication skills

Education

BS/BA in life sciences or computer science

Tools

Rave EDC

SAS LSAF

Pinnacle 21

Job description

The Clinical Data Standards Architect (CDSA) - Data Collection and Delivery implements and maintains efficient standard content in the data collection and delivery tools, and defines and maintains the standard metadata supporting the data flow from data collection to data delivery.

The CDSA configures standards to the specific needs and requirements of a Therapeutic Area or Disease Area, generating expected efficiencies through optimal adoption and reuse of standards. The CDSA also supports the functions adopting these standards in clinical trials, in close collaboration with the clinical data collection team.

The CDSA is responsible for implementing efficient standards in the Rave EDC system (Medidata Solutions).

Responsibilities:

• Implements standard content in data collection and delivery tools to create efficiencies, ensure consistency across trials, and automate CRF build and data flow from collection to SDTM.
  • Examples include:
  • Standard Case Report Form Mockups
  • Standard Questionnaires, Rating Scales, and Clinical Outcome Assessments
  • Standard Validation Rule Specifications
  • Standard Integrations (e.g., with IWRS)
• Implements standard content in collection and delivery tools compliant with industry standards and health authority regulations, following best computer system validation practices where applicable.
• Responsible for testing and QC of collection tools and mapping metadata, collaborating with the respective functions in Data Analysis and Reporting.
• Defines and maintains standard clinical data collection and delivery standards for use in clinical trials.
• Maintains data collection, delivery, and metadata standards at a master level to support scientific or operational requirements, ensuring formal change management control and versioning.
• Governs all changes to standards and manages multiple versions aligned with clinical trial needs.
• Pre-configures standards according to data lifecycle plans, maintaining traceability and lineage of data, and documents the lineage between master standards and pre-configured standards.
• Provides support to the clinical data standards team and clinical analysis team for consistent standard adoption in studies.
• Data delivery focus only: Annotates CRFs with SDTM metadata and collaborates on correctness and compliance with submission, scientific, and operational guidelines.

Education and Experience:

• Deep expertise in Rave EDC (Medidata Solutions)
• Experience with SAS programming; coding experience preferred
• Knowledge of Rave EDC (Medidata Solutions)
• Expertise with CDISC standards: SDTM, CDASH, Controlled terminology, define.xml
• Experience with SAS LSAF and Pinnacle 21
• BS/BA in life sciences or computer science or equivalent experience
• At least 2 years of relevant operational experience in clinical data management or standards
• Operational experience in clinical data standards is preferred
• Ability to prioritize and manage multiple tasks
• Excellent written and verbal communication skills in English

This role is not eligible for UK visa sponsorship

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of medical treatments, aiming to improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com