Clinical Data Standards Architect - Data Collection in basel

veröffentlicht
Kontakt
Réka Szitter, Zürich IT Professionals
Jobtyp
Contract
jetzt bewerben

job details

veröffentlicht
Ort
basel, Basel-Stadt
Sektor
IT
Jobtyp
Contract
Referenznummer
16031
Kontakt
Réka Szitter, Zürich IT Professionals
Telefon
058 201 56 60

Stellenbeschreibung

Are you an experienced Clinical Data Standards Architect - Data Collection and you are looking for an exciting opportunity in the pharmaceutical sector?

Then you should read on! 

In this position you will have the opportunity to work as a Clinical Data Standards Architect on a contracting project (1 year).

Tasks and responsibilities:

  • You will implement and maintain the efficient standard content specifications for data collection tools (eCRF and eCOA) that can be applied across all the disease areas and therapeutic areas or that are specific to a specific therapeutic area or disease area

  • You will define and maintain the standard collection metadata supporting the data flow from data collection to data delivery (SDTM)

  • You are 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

  • You will configure 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

  • You will support the functions adopting the standards in the clinical trials

  • You are responsible for collaborating with an external service provider implementing efficient standards in the Rave eDC system (Medidata Solutions) and guaranteeing quality

Qualifications:

  • BS/BA degree in life sciences or computer science or equivalent work experience

  • 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

  • 3years 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

Have we sparked your interest? Do not hesitate to go ahead and apply!