Principal, Data Delivery Standards

The Principal, Clinical Data Standards - Data Delivery Standards takes a leadership role in the definition and maintenance of standard metadata supporting the data flow from data collection to data delivery. They are responsible for implementing efficient standards that cover all data capture tools and mechanisms. They are responsible for scientific and operational correctness of the metadata standards in support of the R&D portfolio of drug development programs.

They take a leadership role in configuring standards to the specific needs and requirements of a Therapeutic Area, compound our Disease Area, generating the expected efficiencies through optimal adoption and reuse of standards. They also support the functions adopting the standards in the clinical trials, in close collaboration with the clinical programming (CP) team.

They develop deep expertise in industry standards related to data collection and delivery such as Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), Controlled Terminologies (CT) and Therapeutic Area User Guides (TAUG).

They can provide leadership in managing CDS&T staff (internal and contractor/flex) based in India

**Key Responsibilities**:

- If having direct line reports, they will provide the leadership in managing and developing employees. This includes, but is not limited to: Goal and objective setting, periodic performance evaluation, development plans, career planning
- Take a leadership role in guaranteeing the correctness of the annotated case report form meeting submission, scientific and operational requirements, and guidelines.
- Lead the definition and maintenance of data delivery metadata for use in clinical trials. Responsible for the mapping, and derivation metadata used for automating the data flow from data collection tool (e.g., eCRF, DTA) to the Data Review Model (DRM) and from DRM to SDTM Datasets.
- Take a leadership role in guaranteeing that the testing and the validation of the transformation logic in the mapping and derivation metadata meets functional and regulatory requirements and therefore collaborates with the CP function in IDAR.
- Collaborate with the Data Collection Standards team for scientific correctness of the metadata, with the Data Analysis Standards team for guaranteeing the delivery of metadata that meets the analysis requirements and with the Submissions and Regulatory Intelligence team for the compliance of the metadata with industry regulations.
- Responsible for coordinating the accurate implementation of the metadata supporting the Standard Data Transfer Agreements (DTA) with third party vendors. Work closely with the data collection standards team responsible for developing and maintaining the DTAs and with the representatives from the third-party vendors for the accurate implementation of the metadata.
- Take a leadership role in documenting, implementing, and maintaining scientifically and operationally correct traceability between domain and variable metadata across the different metadata models, regardless of the mechanism of collection. Set-up the standard metadata conformant to the industry standards and health authority regulations.
- Coordinate the maintenance of the data delivery metadata standards at a master level to meet additional scientific or operational requirement supporting the R&D portfolio. Guarantee formal change management control and versioning of the standards is applied and adhered to. Formally govern all the changes to standards and handle multiple versions in line with adoption needs of the clinical trials and drug development programs.
- Take a leadership role in the pre-configuration of the standards to the specific data requirements of a therapeutic area or disease area and in line with the specifications of the data lifecycle plan, if applicable, while maintaining the traceability and lineage of the data. Responsible for documenting and accurately handling the lineage between master standards and the many pre-configured standards.
- Guarantee adequate documentation of the standards in studies, offers tailored and effective training, and targets communication to the user community.
- Provide the necessary support to the CP team and other functions, when required, and facilitate the consistent adoption of standards in the studies (internally or outsourced to a CRO). Use metrics to identify potential improvements in the adoption of standards in the studies to enhance the value of standards.
- Lead or participate in process, system, and tool improvement initiatives across Clinical Data Standards and Integrated Data Analytics and Reporting (IDAR).
- Responsible for acquiring and maintaining good understanding of the various data collection tools applied in the clinical trials such as Rave eDC and DTAs. Acquire and maintain a deep expertise in Clinical Data Tools such as LSAF and Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and de