Zuid-Holland , Netherlands
Data Delivery (Clinical Data Standards)
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
You'll be implementing and maintaining efficient standard content specifications for the data collection tools (eCRF and eCOA) that can be applied across all the diseases areas and therapeutic areas. Furthermore, you'll also support the functions by adopting the standards in the clinical trials.
- 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.
- 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
For more information please contact Guilherme Tokunaga at firstname.lastname@example.org or +31 (0) 20 658 98 01.