For one of our leading Biotech clients I'm looking for a Clinical Data Standards Architect with Rave eDC, SAS programs and CDISC standards experience.
- 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.
- 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 Areas, while maintaining the traceability and lineage of the meta data.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
- 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.
- 1st of July
- 12 months
If you’re interested in the above description, please apply with your CV. For further information, please contact Selin Ozbeden at +31 (0)20 20 44 502 or by email at email@example.com