CDISC Expert

CDISC Expert US, India, UK and Switzerland

The ideal candidate will be a detail-oriented database specialist who is able to assist in the implementation and support of a relational database used in clinical research studies. The database specialist will assist in the design, development, validation, implementation and ongoing support of the electronic systems, tools and programs used by the clinical research and development group. This person will be responsible for the development, peer review and maintenance of database systems and tools to support Clinical Research activities. The database specialist will provide content expertise for programming activities from clinical study startup through the statistical analysis stage of clinical studies and will assist with the integration, aggregation and delivery of clinical study data. In addition, this role will participate in the identification, evaluation, recommendation, implementation, and management of clinical information technology solutions to support clinical study database activities.
It is expected that the database specialist will maintain an understanding of Clinical Data Interchange Standards Consortium (CDISC) standards, terminology and models.
The database specialist must conduct all work activities incompliance with all relevant regulatory requirements, GCP, ICH, PhARMA and international guidelines as well as all clients’ policies and procedures.
Other activities, special projects and assignments may be given as required.

Position Requirements:

  • Experience with Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).
  • Expert knowledge of relational database structure and terminology
  • Proficient inStructured Querying Language (SQL) in a SQL Server 2008 environment
  • Experience in SQL Server Integration Services (SSIS)
  • Proven critical-thinking skills and demonstrated ability to manage large biological and/or clinical data sets
  • Proficiency in Microsoft Excel or other spreadsheet applications
  • Strong interpersonal and communication skills with a confident and cooperative service-oriented attitude; professional demeanor and appearance
  • Possess strong work ethic; is reliable, punctual, thorough, and trustworthy
  • Fluency in both written and spoken English

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