Clinical Data Standards Architect (CDSA) - Data Collection (m/f/d)

REFERENCE NUMBER:

546000/1

MY DUTIES:

- 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.
- Standard Case Report Form Mockups
- Standard Questionnaires, Rating Scales and Clinical Outcome Assessments
- Standard Validation RuleSpecifications
- 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.

MY QUALIFICATIONS:

- 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
- Some 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

MY BENEFITS:

- A highly motivated team and an open way of communication
- Remote Globally

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Athina Hondroulidou

Reference number
546000/1

Contact
E-Mail: [email protected]