Clinical Data Standards Architect
Our global Pharmaceutical client based in leafy Buckinghamshire has now reached out to Quanta to assist them with their search for two Clinical Data Standards Architects.
This is a really exciting time to joint this new project and be involved with the team on this new journey.
- 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 or that are specific to a specific therapeutic are or disease area.
- The CDSA defines and maintains the standard collection metadata supporting the data flow from data collection to data delivery (SDTM). To that end the CDSA is responsible for defining and maintaining the metadata supporting the CRF and consulting with the CDSA responsible for data delivery metadata (SDTM) for compliance with the SDTM standard.
- 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 also supports the functions adopting the standards in the clinical trials
We are lookig for candidates with the following experience:
- 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
- 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
We are offering an extremely high hourly rate for these new and exciting positions.
If this is of interest to you, please do get in touch.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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