Environmental Manager ensuring compliance and sustainability for major infrastructure construction projects. Collaborating with project teams to implement environmental management systems and oversee environmental issues.
About the role
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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