Possible Location: UK, Spain, Belgium, South Africa, Romania, Hungary, Ireland, France, Italy, Czech Republic, Bulgaria.

Job Description Summary

This unique role within IQVIA is ideal for someone with a technical mindset, strong communication skills, and a good understanding of SDTM.

Experience in Study Design, CRF annotation, CDISC standards, and vendor management will be key for success in this position. The role can be performed remotely from a number of countries in Europe or South Africa.

As part of a dedicated sponsor team, you will work directly with the client to manage database and CRF-related activities while overseeing SDTM deliverables throughout the study lifecycle.

The primary responsibility of this role is to provide end-to-end oversight of SDTM activities. This includes managing CRF design based on study protocols, ensuring vendor specifications align with SDTM requirements, contributing to SDTM specifications when required, and performing SDTM review and oversight to ensure the quality, consistency, and completeness of SDTM datasets and deliverables.

Main responsibilities include:
• Collaborate with Sponsor colleagues and CRO Partners to review CRF design and compliance into standard and 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
• Map SDTM data and manage annotated CRF
• 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:
• At least 5 years relevant in either SDTM oversight and/or CRF design
• 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 is an added value
• 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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.