Senior Clinical IT & Data Oversight Manager ensuring integrity and compliance of clinical IT systems and trial data. Overseeing vendor systems and supporting data workflows in clinical development activities.
Responsibilities
Tracking and monitoring of clinical IT systems, ensuring compliance with regulatory requirements (e.g., GxP, GDPR, FDA 21 CFR Part 11); supporting audits, risk analyses and system assessments
Coordination of system updates and change management activities with vendors/service providers, including decommissioning and issue management
Support of qualification and validation processes for data transfers and interfaces to optimize clinical data workflows together with Clinical Data Management
Contributing to sponsor data quality monitoring through targeted data reviews, trend analyses, and use of data analysis and visualization tools (e.g., SAS, SQL, Python, Power BI)
Supporting documentation processes, including identification, transfer and archiving of essential system- and data-specific documents
Promoting cross-functional collaboration with Clinical Development, Product Safety, QA and external partners, including providing 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
Requirements
Academic degree, preferably in Data Science or IT/Computer Science
3 years' experience in setting up and/or qualifying IT systems in a GCP-regulated environment
At least 3–4 years' 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 skills (e.g., SAS, SQL, Python) and hands-on experience
Strong communication skills; well organized, reliable, with a proactive and collaborative mindset
Interest in IT topics and clinical development, and motivation to adopt and further develop procedures and tools for effective sponsor oversight
Benefits
Individual career development focused on improving quality
Hybrid working model enabling a good work–life balance
Attractive location with good transport links, modern workspaces and company cafeterias
International family-owned company with flat hierarchies and an open, appreciative corporate culture
Competitive compensation with comprehensive social benefits
A range of employer-sponsored benefits such as WellPass, Deutschlandticket (public transport pass), Corporate Benefits and JobBike
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