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Niche clinical data programming skills reduce applicant density despite remote flexibility.
Clinical trial CDISC/CDASH expertise is industry-specific and not easily transferable.
Mandatory Medidata Rave, C# and CDISC/SDTM skills enforce strict technical screening.
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Develop and maintain trial-specific clinical and non-clinical databases, including eCRFs and edit checks, using relevant programming languages to high quality within set timelines.
Support programming of standardized reports and listings for data review and analysis utilized by external partners and vendors.
Assist in developing and maintaining CDASH-compliant therapeutic area and global eCRF libraries aligned with current SDTM standards.
Experience with Medidata Rave build, including eCRFs, edit checks, and migrations.
Proficiency in C# programming, including custom function development.
Good knowledge of CDISC, CDASH, and SDTM implementation guidelines.
Work Experience Required: Not explicitly mentioned in the JD.
Experienced in clinical trial data operations programming with focus on eCRFs and data standardization processes.
Collaborative operator comfortable working in teams, supporting colleagues, and promptly communicating timeline or workload risks.
Technically skilled with programming languages relevant to clinical data management and knowledgeable about regulatory data standards.