Jobs in der Softwareentwicklung in Schweiz

Functional Goal: Provision of data management expertise from study design to submission to Regulatory Authorities. On behalf of Fresenius-Kabi SwissBioSim, lead oversight of data management activities outsourced to external partners. Provide support to but not limited to CRO selection, GxP adherence, Inspection readiness, Protocols, SAPs and other relevant clinical study documents. Accountability for Data Management KPIs. Main Tasks: Strong technical expertise to ensure completeness, correctness and consistency of clinical and non clinical data in all studies/programs to achieve results in agreement with defined quality specifications and timelines Manage and troubleshoot operational challenges and GCP compliance Promote standardization in collaboration with Biostatistics and other colleagues to improve consistency across all programs Track emerging trends and apply them to improve data management support across all programs Lead the development of CRFs/eCRFs, edit checks, reconciliation plans, data communication plans, data transfers, SDTM packages and routine reports to track data collection/quality progress Contribute to the development of electronic submission packages Review of clinical study protocols and SAPs/mock TLFs. Provide input for high level forecasting of timelines for data management tasks and estimation of resources and budget Subject Matter Expert for audits and inspections Participate in the selection process of CROs and provide oversight of outsourced activities Collaborate effectively with cross-functional teams and external partners Develop, review, update, and add SOPs as company/situations evolve when applicable Other Tasks: Provide timely feedback and solutions to management regarding staffing needs and individual performance Recruit new staff, onboard and manage new employees as needed Interact proactively and solution orientated with other clinical and non clinical functions