Overview
Location: Remote (UK, Spain, Soutch Africa, Hungary, Ireland, Italy, Portugal, Czech Republic, Bulgaria, Belgium)
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:
o Review of SDTM annotated CRFs
o Writing and reviewing technical specifications
o Reviewing log files for errors and warnings
o Resolving/troubleshooting errors
o 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.
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
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