Associate Director, Clinical Data Management Programming | Software Engineer (m/w/d)

BioNTech SE

Mainz am Rhein, Rheinland-Pfalz, Deutschland
Published Nov 5, 2025
Full-time
No information

Job Summary

This strategic leadership role requires an experienced Associate Director to significantly enhance global clinical programming and database setup capabilities within a fast-paced, innovative environment. The core responsibilities include providing technical expertise and administration for Medidata Rave applications (EDC, iMedidata, Coder), ensuring regulatory compliance (ICH, GCP, 21 CFR Part 11), and maintaining data integrity across global clinical trials. Day-to-day tasks involve programming database screens, dynamics, and complex edit checks, managing post-production changes, and developing advanced reports, tools, and dashboards using data visualization technologies like SAS and Business Objects. The ideal candidate will lead technical initiatives, optimize CDM processes, manage the global standard library, and collaborate closely with cross-functional teams (IT, Clinical Operations) to deliver high-quality data solutions for submissions.

Required Skills

Education

Bachelor's degree, preferably in computing, engineering, or scientific discipline or equivalent experience

Experience

  • 10+ years in clinical data management in biotechnology, CRO, or pharmaceutical industry
  • 8+ years of Electronic Data Capture (EDC) study build and administration experience (EDC Study builder, Migration Programmer, CF Programmer, EDC Systems administrator)
  • Professional experience with Medidata Rave EDC System administration
  • Professional experience with Medidata applications
  • Strong knowledge of Data Management processes and systems
  • Understanding of clinical drug development processes

Languages

English (Fluent)

Additional

  • Experience with 21 CFR Part 11 compliant systems requiring validated implementation; Strong organizational skills; Demonstrated problem-solving abilities in a team environment; Ability to work in a fast-paced environment.