Skechers Store Manager responsible for customer satisfaction and sales at Paris retail location. Leading a dynamic team and ensuring smooth daily operations.
About the role
- Join a team as Senior Clinical IT & Data Oversight Manager ensuring the integrity, quality and compliance of clinical IT systems. Oversee vendor systems and contribute to digital excellence in clinical development.
Responsibilities
- Join our motivated team as Senior Clinical IT & Data Oversight Manager (m/f/d)
- Oversee vendor systems, support data workflows, and contribute to the digital excellence of clinical development activities
- Track and oversee clinical IT systems, ensuring compliance with regulatory requirements (e.g., GxP, GDPR, FDA 21 CFR Part 11)
- Support audits, risk assessments, and system evaluations
- Coordinate system updates and change management activities with service providers
- Support qualification and validation of data transfers and interfaces to optimize clinical data workflows together with Clinical Data Management
- Contribute 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)
- Support documentation processes including identification, transfer, and archiving of essential system- and data-related documents
- Drive cross-functional collaboration with Clinical Development, Product Safety, QA, and external partners
- Participate in audits and budget planning for clinical IT systems and contribute to the evaluation and implementation of new digital tools
Requirements
- 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 focused on improving quality
- Hybrid work model that supports a good work–life balance
- Attractive location with good transport links, modern workplaces, and company restaurants
- International family-owned company with flat hierarchies and an open, appreciative corporate culture
- Competitive compensation with comprehensive social benefits
- Variety of employer-subsidized benefits such as WellPass, Germany ticket, Corporate Benefits, and JobBike
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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