Beschreibung

As a Senior Clinical IT & Data Oversight Manager, you will ensure the integrity and compliance of clinical IT systems while optimizing data workflows. This role involves collaborating across teams, supporting audits, and leveraging data analytics to enhance clinical development activities.

Anforderungen

• •Academic degree 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
• •Motivation to own and develop procedures and tools for effective sponsor oversight

Aufgaben

• •Track and oversee clinical IT systems
• •Ensure compliance with regulatory requirements
• •Support audits, risk assessments, and system evaluations
• •Coordinate system updates and change management activities
• •Manage decommissioning and issue resolution
• •Support qualification and validation of data transfers
• •Optimize clinical data workflows with Clinical Data Management
• •Contribute to sponsor data quality oversight
• •Conduct critical data reviews and trend analysis
• •Utilize data analytics and visualization tools
• •Support documentation processes for system and data-related documents
• •Drive cross-functional collaboration with Clinical Development and QA
• •Provide training on compliance expectations
• •Participate in audits and budget planning for clinical IT systems
• •Evaluate and implement new digital tools

Tools & Technologien

Benefits