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  • Location

    Leiden, Netherlands

  • Job title:

    Clinical Data Standards Architect - Collection

  • Sector:

  • Job ref:

    46267

  • Start Date:

    2021-06-03

The Company 
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of monoclonal antibodies to protect people worldwide from immunological diseases.

Role Description 
As a Clinical Data Standards Architect you will implement and maintain standard content specifications for the data collection tools (eCRF and eCOA) across different therapeutic areas. 
You will also collaborate with an external service provider implementing efficient standards in the Rave eDC system (Metadata solutions). 


Responsibilities
- Define the specification of standard content in the data collection tools, primarily Rave with the goal of maintaining efficiency and consistency across trials and automating the CRF build. 
- Ensure that collection tools are compliant to the industry standards, health authority regulations and CSV practices. 
- Quality Control of the data collection tools. 
- Manage all the standard changes in line with the clinical trials needs and drug development programs. 
- Tailor the global standards to specific needs of Therapeutic areas. 
- Provide support to the clinical data management teams to achieve consistent adoption of standards in the studies (internally or outsourced to a CRO). 


Requirements
- Bachelor's Degree in Computer Science or Life Sciences 
- 3 years of experience in a similar role, experience with clinical data standards strongly preferred
- Expertise in Rave eDC 
- Expertise with SAS programs 
- Expertise with CDISC standards: SDTM, CDASH and Controlled terminology is required
- Experience with SAS LSAF and Pinnacle 21 is a plus


Other Information 
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01. 

 

Contact us

SIRE® LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE® STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804