Clinical Data Standards Architect - Data Collection

---

Job description

At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

Services Overview:

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

The CDSA is responsible for collaborating with an external service provider implementing efficient standards in the Rave eDC system (Medidata Solutions) and guaranteeing quality.

Deliverables:

* 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. Examples
* Standard Case Report Form Mockups
* Standard Questionnaires, Rating Scales and Clinical Outcome Assessments
* Standard Validation Rule Specifications
* Standard Integrations (e.g. with IWRS)

* 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 Ares, while maintaining the traceability and lineage of the metadata. 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

Interfaces - Primary/Other:

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

Education and Experience Guidelines:

* 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

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel's human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.