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 Project Manager with strong communication skills and SDTM knowledge. Having experience with SAS programming will also be a huge benefit. 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 Delivery from external vendors.
The primary functions of this role will be to build study eCRFs in Formedix Ryze (Certara), define structure of datasets that are part of data transfer specifications and ensure quality and completeness of SDTM format data.
Primary Functions:
Build study eCRFs in Formedix Ryze (Certara)
Define dataset structures for data transfer specifications
Ensure quality and completeness of SDTM format data
Main Responsibilities:
Collaborate with Sponsor colleagues and CRO Partners to finalize the design, creation, and implementation of EDC solutions.
Work with Study Data Leads to plan for data receipt and oversee it throughout clinical trials.
Process data loads from various sources into clinical and operational data repositories, including reviewing and communicating issues.
Program reports and contribute to the standardization of processes and reports for data review and analysis for external partners/vendors and internal teams.
Complete formal and ad-hoc analyses and oversight of SDTM data.
Review critical documents/deliverables (SDTM Annotation, SDTM datasets) to ensure consistent use of Data Standards and support the creation of DE datasets.
Attend meetings with various teams (Mission, Submission, Project, Program, JCST, DEM, Biometrics, Clinical & Regulatory Solutions Team (CRST), Early Phase)
Perform quality checks and create standard edit checks for new CRF modules.
Support audits and inspections as required and handle other responsibilities and projects assigned by the Company.
Experience Required:
Substantial experience in relational database design.
Substantial experience with SAS programming preferred.
Experience with Data Management processes, including:
Review of SDTM annotated CRFs
Writing and reviewing technical specifications
Reviewing log files for errors and warnings
Resolving/troubleshooting errors
Data mapping and SDTM Controlled Terminology.
Prior experience in a clinical or pharmaceutical-related field.
Prior experience in a Data Management-related field.
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 of English, both verbal and written.
Apply via company website ( https://www.iqvia.com ) or
jobs.iqvia.com