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.

Responsibilities

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

Profile

Academic degree, preferably 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

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 subsidised benefits such as WellPass, Germany ticket, Corporate Benefits and JobBike

Bewerben URL