Clinical Data Standards Architect

Contenuto del lavoro

For our client, a pharmaceuticals and biotechnology company based in Allschwil, we are currently looking for a Clinical Data Standards Architect.

The Clinical Data Standards Architect (CDSA) - Data Delivery implements and maintains efficient standard content in the data delivery tools (SAS, LSAF Excel based libraries) 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 delivery metadata supporting the data flow from data collection to data delivery (DRM and SDTM). To that end, the CDSA is responsible for defining and maintaining the metadata supporting the Data transfer Agreements (DTA) with third parties, DRM and SDTM model and the data mapping of source data, eCRF data and third-party transfer data (eDT) to DRM and SDTM.

The CDSA configures standards to the specific needs and requirements of a Therapeutic Area, compound, or Disease Area, generating the expected efficiencies through optimal adoption and reuse of standards. The CDSA also supports the functions adopting the standards in the clinical trials, in close collaboration with the CDSA responsible for the data collection standards.

Deliverables:

• Implement the standard metadata in the data delivery tools with the goal of creating efficiencies within the trials, consistency across the trials and automating the data flow from source data to DRM and to SDTM

Examples:

o Study Data Tabulation Model (SDTM)

o Annotated Case Report Forms (CRFs)

o Support the data transfer agreement (DTA) standards with SDTM

o Data Review Model (DRM)

o Mapping metadata from data collection (CRF and DTA) to DRM

o Mapping metadata from DRM to SDTM

• Implement standard content in the delivery tools compliant to the industry standards and health authority regulations, meeting best practices in computer system validation, where applicable
• Responsible for the correct testing and QC of the mapping metadata and therefore collaborates with the respective functions in Integrated Data Analysis and Reporting (IDAR)
• Annotate the eCRF or eCOA with SDTM metadata and collaborates with his/her team members on the correctness of the annotated case report form meeting submission, scientific and operational requirements, and guidelines
• Define and maintain the clinical data delivery standards in line with the needs in clinical trials to meet additional scientific or operational requirements. To that end you will guarantee that formal change management control and versioning of the standards is applied and adhered to
• Govern formally all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs
• Provide the necessary support to the clinical programming teams to achieve consistent adoption of standards in the studies (internally or outsourced to a CRO). To that end, you pro-actively support identifying the standards supporting the trial objectives.
• • Tailor the global standards to the specific needs of Therapeutic Areas or Disease Ares, while maintaining the traceability and lineage of the metadata. Document and correctly manage the lineage between global standards and the pre-configured (tailored) standards.
• Provide the necessary support to the clinical programming teams to achieve consistent adoption of standards in the studies (internally or outsourced to a CRO). To that end, you pro-actively support identifying the standards supporting the trial objectives.

Interfaces – Primary/Other:

• Primary interfaces: The clinical data standards team and the data acquisition experts and the data managers in the data management function and the clinical programmers.
• Other Interfaces: Clinical Analysis Standards, the clinical team (statistician, physician, …), CDISC working groups.

Education and Experience Guidelines:

• Experience with coding and running SAS programs is required
• Knowledge of Rave eDC (Medidata Solutions) is a preferred
• Expertise with CDISC standards: SDTM, Controlled terminology and define .xml.
• 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

If this role excites you, and you feel you could take this next challenge in your career, then I look forward to receiving your application today.

Please note that we are only considering applications from Swiss and EU-27/EFTA nationals or Swiss work permit holders for our open positions in Switzerland.