DM/STDM Programmer Oeiras

Overview

Location: Remote (UK, Spain, Soutch Africa, Hungary, Ireland, Italy, Portugal, Czech Republic, Bulgaria, Belgium)

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 e
CRFs 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 e
  CRFs 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
  - 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
  - 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.

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Engineering and Information Technology

Industries

• Pharmaceutical Manufacturing

We’re unlocking community knowledge in a new way. Learn more at https://jobs. iqvia.com