CDISC Expert

Experiance:

8-10

Job Description:

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

Qualification:

  • 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.

Mail us:

Head office

            Suite # 313,

    103 Carnegie centre,

             NJ 08540

Tel:  469-964-5336

Other Locations

Jammu,  India

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