Senior Clinical IT & Data Oversight Manager (m/f/d)

Join our motivated team as Senior Clinical IT & Data Oversight Manager (m/f/d) and play a key role in ensuring integrity, quality and compliance of clinical IT systems and trial data. In this position, you will oversee vendor systems, support data workflows, and contribute to the digital excellence of our clinical development activities. 

Your responsibilities will include the following:

• Tracking and overseeing clinical IT systems, ensuring compliance with regulatory requirements (e.g., GxP, GDPR, FDA 21 CFR Part 11); supporting audits, risk assessments and system evaluations
  
  


• Coordinating system updates and change management activities with service providers, including decommissioning and issue management
  
  


• Supporting qualification and validation of data transfers and interfaces to optimize clinical data workflows together with Clinical Data Management
  
  


• Contributing to sponsor data quality oversight through critical data review, trend analysis and the use of data analytics and visualization tools (e.g., SAS, SQL, Python, Power BI)
  
  


• Supporting documentation processes including identification, transfer, and archiving of essential system- and data-related documents
  
  


• Driving cross-functional collaboration with Clinical Development, Product Safety, QA and external partners, including training on compliance expectations
  
  


• Participating in audits and budget planning for clinical IT systems and contributing to the evaluation and implementation of new digital tools