Location
Remote (UK, Spain, South Africa, Hungary, Ireland, Italy, Portugal, Czech Republic, Bulgaria, Belgium)
Role Overview
This unique role within IQVIA lends itself to a technically minded person with strong communication skills and SDTM knowledge. Having experience with SAS programming will be key for this position. The role can be based remotely from anywhere in Europe or in South Africa. This role is part of a sponsor dedicated project where you will be working with the client directly to manage Database SDTM Deliveries. The primary functions of this role will be to define SDTM specification and Programming including SDTM review ensuring quality and completeness of SDTM format data.
Primary Functions
* Review and programming of SDTM deliveries
* Build and review SDTM submission packages
* Ensure quality and completeness of SDTM format data
Main Responsibilities
* Collaborate with Sponsor colleagues and CRO Partners to review SDTM
* In collaboration with Study Data Leads ensure planning for data receipt and oversight throughout the duration of assigned clinical trials
* Program reports and contribute to the standardization of process and reports used for data review and analysis for external partners/vendors and internal teams
* Complete formal and ad‑hoc analyses and oversight of SDTM data
* Review of critical documents/deliverables (SDTM Annotation, SDTM datasets) to ensure Data Standards are used consistently and support creation of DE dataset
* Program either SDTM SAS PRD or SAS QC of some SDTM deliveries managed internally
* Attend meetings as applicable with Mission, Submission, Project, Program, JCST, DEM, Biometrics, Clinical & Regulatory Solutions Team (CRST), Early Phase
* Perform relevant quality checks and create standard edit checks for new CRF modules and share in the appropriate space
* Support audits and inspections as required and other responsibilities and projects that the Company may assign
Experience Required
* At least 5 years relevant SAS experience preferred
* Experience with Biometrics processes, to include:
* Review of SDTM annotated CRFs
* Writing and reviewing technical specifications
* Review of log files for errors and warnings
* Resolving/troubleshooting errors
* Experience with data mapping and SDTM Controlled Terminology
* Experience with SAS programming and SDTM deliveries
* Prior experience in a clinical or pharmaceutical related field is required
* Prior experience in a Data Management related field is required
* Experience with relational databases, preferably Clinical Data Management and EDC Systems
* Advanced familiarity with reporting tools
* Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices
* Excellent command, both verbal and written, of English
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