We are looking for a cdisc expert
Roles and Responsibilties:
Define, further develop and implement CDISC Standards (SDTM) incl. Define.xml
Define, further develop and implement Clinical Data Collection Standards (eCRF) - general and therapeutic area standards
Ensure Quality of Data Standards and Formats for Submission of Data to Health Authorities
Ensure CRO and data quality surveillance by designing, developing and supporting Data Quality surveillance processes and tools
Review of CRO and other internal and external third parties deliveries (Data Quality, Data Formats, Timelines), identify and resolve issues with partners
Collaborate with the CRO and other internal and external third parties on process and continuous improvement initiatives
Contribute to (e-)submission strategies regarding submission relevant data
Lead or Co-Lead Projects (standards related, technical, process improvement, innovation projects) in the area of Global Clinical Data Sciences, Data Management
Master’s degree in Life Sciences, Mathematics or Computer Sciences with 8 years extensive industry experience will be considered.
Excellent CDISC expertise (SDTM and Controlled Terminology).
Excellent Expertise in Clinical Data Standards and CRF design.
Experience / or in-depth knowledge in pharmaceutical industry and processes with long professional experience in Data Management (min. 6 years).
Very good programming skills (especially SAS).
Comprehensive knowledge of ICH-GCP.