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 the planning for data receipt and its 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 document/deliverable (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/trouble shooting 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