Job Details

Clinical Data Standards Architect: Data Collection

Not Specified, United Kingdom, Contract

Posted: 3 hours ago


PE Global is currently recruiting for a Clinical Data Standards Architect (Data Collection) for a 12-month contract role with a leading multinational Pharma client. Fully remote role.

• The CDSA defines the specification of standard content in the data collections tools, primarily Medidata Rave, with the goal of creating efficiencies within the trials, consistency across the trials and automating the CRF build and the data flow from collection to SDTM. Examples
• Standard Case Report Form Mockups
• Standard Questionnaires, Rating Scales and Clinical Outcome Assessments
• Standard Validation Rule Specifications
• Standard Integrations (e.g. with IWRS)

• The CDSA implements standard content in the collection tools compliant to the industry standards and health authority regulations, meeting best practices in computer system validation, where applicable.
• The CDSA is responsible for the correct testing and QC of the collection tools and therefore collaborates with the respective functions in Integrated Data Analysis and Reporting (IDAR).
• The CDSA defines and maintains the clinical data collection standards in line with the needs in clinical trials to meet additional scientific or operational requirement. To that end the CDSA will guarantee that formal change management control and versioning of the standards is applied and adhered to.
• The CDSA governs formally all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs.
• The CDSA tailors the global standards to the specific needs of Therapeutic Areas or Disease Ares, while maintaining the traceability and lineage of the metadata. The CDSA documents and correctly manages the lineage between global standards and the pre-configured (tailored) standards.
• The CDSA provides the necessary support to the clinical data management teams to achieve consistent adoption of standards in the studies (internally or outsourced to a CRO). To that end, the CDSA pro-actively support identifying the standards supporting the trial objectives.

• Deep expertise in Rave eDC (Medidata Solutions).
• Experience with running SAS programs, coding experience preferred.
• Expertise with CDISC standards: SDTM, CDASH and Controlled terminology is required.
• Experience with SAS LSAF and Pinnacle 21 is a plus.
• BS/BA degree in life sciences or computer science or equivalent by work experience.
• 3 years of relevant operational experience in clinical data management and standards is essential.
• Relevant development experience in clinical data standards is strongly preferred.
• Experience in prioritizing and managing multiple tasks simultaneously.
• Outstanding written and verbal communication skills in English.

Interested candidates should submit an updated CV
Please click the link below to apply, call Alba on (phone number removed) or alternatively send an up to date CV
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

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Job Details

Not Specified, United Kingdom