Associate Director, Clinical Data Management Programming | Software Engineer (m/w/d)
BioNTech SE
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
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.
More Jobs from BioNTech SE
Manager, Global Operational Resilience | Economist (m/w/d)
Nov 6, 2025
This role as Manager, Global Operational Resilience involves joining the Global Security & Protectio...
Director, CMC Materials for Individualized Cancer Vaccines | Pharmacist (m/w/d)
Nov 6, 2025
This Director role in Mainz, Germany, demands strategic leadership and coordination of a cross-funct...
Director of Corporate and Financial Communications | Director (m/w/d)
Nov 6, 2025
This Director role at BioNTech focuses on shaping and executing strategic corporate and financial co...