Senior Clinical IT & Data Oversight Manager (mfd)

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 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
• 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 34 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

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

Required Experience :

Unclear Seniority

Key Skills

IT Experience,Business Continuity Planning,IT Management,SAAS,Desktop Administration,Computer Networking,Management Experience,Salesforce,IT Service Management,ITIL,Azure,Project Implementation

Employment Type : Full-Time

Experience : years

Vacancy : 1