Website IQVIA
Sharing a Vision to Drive Healthcare Forward Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increa… read moresingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA COREâ„¢ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward. Southdown's Ridge Office Park 2nd Floor, Unit 5 Corner Nellmapius & John Vorster Drive Irene Ext. 54 Centurion Pretoria South Africa 0169
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
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Apply via company website ( https://www.iqvia.com ) or