Possible Location: UK, Spain, Belgium, South Africa, Romania, Hungary, Ireland, France, Italy, Czech Republic, Bulgaria.
This unique role within IQVIA lends itself to a technically minded person with strong communication skills and SDTM knowledge. Having experience in Study Design, CRF annotation, CDISC standards, Vendor management with SAS programming skills 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 CRF and SDTM Deliveries.
The primary functions of this role will be to oversight all activities related to SDTM end to end. Including the management of CRF design from the protocol, ensuring Vendors specifications are compliant with SDTM needs and defining SDTM specification on some studies and/or SDTM review and oversight, ensuring quality and completeness of SDTM format data.
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 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
• 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.