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YOUR CONTRIBUTION

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
 

YOUR PROFILE

  • Academic degree, preferable in data science or IT/computer science

  • 3 years of experience in setup and/or qualification of IT systems in a GCP-regulated environment

  • At least 3–4 years of experience in Clinical Data Management

  • Understanding of GCP requirements for IT systems; experience with clinical trial systems (e.g., EDC, IRT, eCRF, eCOA, CTMS, eTMF)

  • Fluent English (written and spoken)

  • Strong understanding of IT and data processes

  • Programming knowledge (e.g., SAS, SQL, Python) and hands-on experience

  • Strong communication skills, well-organized, reliable, proactive and collaborative mindset

  • Interest in IT topics and clinical development, and motivation to own and develop procedures and tools for effective sponsor oversight

 

 

YOUR BENEFITS

 

  • Individual career development with the purpose of improving the quality

  • Hybrid work model that allows a good work-life balance 

  • Attractive location with good transport links, modern workplaces and company restaurants

  • International family business with flat hierarchies and an open, appreciative corporate culture

  • Attractive remuneration with extensive social benefits

  • Variety of employer-subsidized benefits such as WellPass, Germany ticket, Corporate Benefits and JobBike

David Brodkorb