Sabine Stegner Email & Phone Number

München, Bayern, Deutschland

Part of the Lean Digital Core Team in Novartis.

Nürnberg

Disciplinary and professional leadership of the Department of Medical Affairs Excellence &Governance:

Nürnberg Und Umgebung, Deutschland

act as local subject matter experts on all operational aspects of local sponsored studies, IIT, MAP and non-interventional trials including coordination of operational systems (e.g. CTMS, DMS, etc.)

Nürnberg

Responsible for Team Quality & Training as group leader: Management of a team of internal and external employees and for local Super User of clinical trial systems (ClinAdmin, iPortal, eCRF) Responsible for Quality Management and Training/ Operational Excellence at GMO Germany: Responsibility for adherence to training / quality standards and processes of local GMO Developing local training curricula, onboarding courses, training modules and methods for local GMO team Monitoring and follow up on mandatory training status of all local GMO associates Active membership of global Quality and training network (also cross divisional) Support and active involvement during Audits& Inspections (local and Country HA, e.g. FDA), CAPA Management Active membership of local Medical SOP Board, Author of local SOPs for GMO Optimization and adaptation of processes for clinical trials in cooperation with other departments (Local/ internal: Medical Oncology and Pharma, Novartis Patient Safety, Purchasing, Legal, Development Quality Assurance) Ensure effective processes and local SME for processes regarding study conduction Ensuring high quality of study conduction according to all relevant regulatory requirements; monitoring of Key Quality Indicators and Novartis Standards/ metrics

Nürnberg

• Identification and selection of external service providers mainly GxP (CRO services within the framework of studies of BU oncology: laboratory services, monitoring, DM / biostatistics)• Contract negotiation and Contracting of local CROs

Nürnberg

Nürnberg

Wehr Am Rhein

Responsible for Clinical Supply Team as group leader: Management of a team of internal employees in a GMP Environment; Responsible for Storage, Packing, Labelling, Distribution and Destruction of IMPs for CPO German as local depot of clinical supply

Nürnberg

Master'S Degree, Biology, General

Main Course Biochemistry

Diploma, Trainings- & Sportmanagement

Bachelor'S Degree, Business Administration