Job Title: DM/STDM Programmer

Job Location: Reading, Berkshire, United Kingdom

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

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: