A Medical Device Client is searching for a: Clinical Data Standards Architect (CDSA) - Data Collection ( Remote Globally) x2 positions
The Clinical Data Standards Architect (CDSA) - Data Collection implements and maintains efficient standard content specifications for the data collection tools (eCRF and eCOA) that can be applied across all the diseases areas and therapeutic areas.
The CDSA defines and maintains the standard collection metadata supporting the data flow from data collection to data delivery (SDTM).
The CDSA configures standards to the specific needs and requirements of a Therapeutic Area, compound, or Disease Area (fit for purpose), generating the expected efficiencies through optimal adoption and reuse of standards.
The CDSA is responsible for collaborating with an external service provider implementing efficient standards in the Rave eDC system (Medidata Solutions).
• 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
o Standard Case Report Form Mockups
o Standard Questionnaires, Rating Scales and Clinical Outcome Assessments
o Standard Validation Rule Specifications
o Standard Integrations (e.g. with IWRS)
• The CDSA is responsible for the correct testing & 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.
• 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 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).
Interfaces – Primary/Other:
• Primary interfaces: The clinical data standards team and the data acquisition experts and the data managers in the data management function
• Other Interfaces: Clinical Analysis Standards, the clinical team (statistician, physician, …), CDISC working groups.
Education and Experience Guidelines:
• Expertise in Rave eDC (Medidata Solutions)
• Experience running SAS programs, coding experience preferred.
• Expertise with CDISC standards: SDTM, CDASH & 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 & standards
• Relevant development experience in clinical data standards is strongly preferred
• Fluent English
Michael Bailey International is acting as an Employment Business in relation to this vacancy.