Remote - Clinical Data Technical Specialist

A highly reputable global pharmaceutical corporation is currently hiring a qualified Remote Clinical Data Technical Specialist.

Position Summary:

• 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, including by not limited to:

• 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, Python, R etc. 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.

Requirements:

• Bachelor’s Degree or higher in the scientific, biological, statistical or computer science field or related discipline.
• Experienced / exposure to data standards in the pharma/biotech industry.
• Experienced / knowledge of Electronic Data Capture tools used in clinical studies.
• Experienced / knowledge of with CDISC CDASH and SDTM.
• Data Programming experience (e.g. SAS, Python, R etc.).
• Experienced working with external data vendors and parsing through documents to gather required information.
• 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.