SDTM - Database Delivery Oversight Lead at IQVIA

Job Description

• 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 in Europe.
• 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, define structure of datasets that are part of data transfer specifications and ensure quality and completeness of SDTM format data.

Main responsibilities include:

• Collaborate with Sponsor colleagues and CRO Partners to finalize the design, creation and implementation of EDC solutions
• In collaboration with Study Data Leads ensure the planning for data receipt and its oversight throughout the duration of assigned clinical trials
• Process data loads from various sources into the clinical and operational data repositories including the review and communication of issues.
• 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
• 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 experience in relational database design
• 2-3 years SAS experience preferred
• Experience with Data Management 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
• 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