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Clinical Data Technical Specialist

4 months ago

Novato, United States Tandym Group Full time

Our client, a leader in the pharmaceutical industry, is seeking a Clinical Data Technical Specialist to join their team.

**This job is a remote position - West Coast Preferred**
**W2 Only**

This contract position will provide support and technical expertise to assist the Clinical Data Management team with data mappings and transformation, data migration between software platforms, data listings/graphs development, testing, and validation, and applying and maintaining data standards (e.g. CDISC) for use in clinical studies.

Responsibilities:

  • Perform and/or review clinical data mappings from multiple data sources to aggregate data using standards
  • Liaise with the external vendor to identify and / or resolve data format, mapping, or structural issues
  • Work closely with the Lead Data Managers, Project Managers, and technical teams to extract/obtain data, transform/derive, and load data per defined requirements
  • Use programming tools such as SAS, SQL to generate and validate reports, graphs and data transformations
  • Provide input on requirements/specifications for Data Aggregation reports
  • Perform user acceptance testing of the reports, graphs, and tables. Provide input on test data requirements
  • Review external vendor data transfer agreements for harmonization and alignment with the data aggregation requirements
  • Develop and/or provide input on training materials
  • Assist with developing processes for Data Aggregation Tool interaction
  • Assist with database migrations of EDC DB
  • Assist with user administration and data access management

Qualifications:

  • Bachelor's degree or higher in the scientific, biological, statistical or computer science field or related discipline
  • Minimum of 2 years of experience in the pharma/biotech industry
  • Experience / knowledge of Electronic Data Capture tools used in clinical studies
  • Experience with CDISC CDASH and SDTM
  • Minimum 2 years of programming experience (e.g. SAS)
  • Experience working with external data vendors and parsing through documents to gather required information
  • Self-directed, technically strong, and able to understand the requirements of several different departments (e.g., clinical data management, biostatistics, statistical programming, medical directors)
  • Ability to independently manage time demands without significant oversight to meet expected completion of stated deliverables and targeted deliverables dates
  • Excellent communication and interpersonal skills
  • Strong analytical and problem-solving skills