DM/STDM Programmer (SDTM)

Location: Remote from anywhere in Europe or South Africa. Possible locations include the UK, Spain, Belgium, South Africa, Romania, Hungary, Ireland, France, Italy, Czech Republic, and Bulgaria.

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Manage end-to-end SDTM activities for sponsor-dedicated clinical trials.
• Review CRF design against protocols, data standards, and SDTM requirements.
• Coordinate data receipt planning and oversight with Study Data Leads, sponsors, CRO partners, and vendors.
• Define, review, and maintain SDTM specifications, mappings, annotated CRFs, datasets, and DE datasets.
• Program reports, analyses, standard edit checks, and quality-control checks for SDTM data.
• Support audits, inspections, meetings, and additional data management projects.

Requirements

• At least 5 years of relevant experience in SDTM and/or CRF design.
• Experience reviewing annotated CRFs, writing and reviewing technical specifications, and resolving log-file errors and warnings.
• Experience with data mapping, SDTM Controlled Terminology, SAS programming, and SDTM deliveries.
• Clinical or pharmaceutical experience and prior experience in data management are required.
• Experience with relational databases, preferably clinical data management and EDC systems, plus advanced familiarity with reporting tools.
• Excellent verbal and written command of English; advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.

Culture & Benefits

• Work directly with the sponsor on a dedicated clinical research project.
• Collaborate with sponsor colleagues, CRO partners, vendors, and multidisciplinary clinical and regulatory teams.
• Remote work is available from the listed European countries or South Africa.