, therapeutical proteins.) - Involvement in the continuous improvement and optimization of quality and processes - Preparation of development strategies and / or reports - Review of validation logs and reports
Management und Report der Studien GMP-Konforme Durchführung und Dokumentation aller Aktivitäten Verantwortlichkeit für das Equipment Qualifikation Abgeschlossenes naturwissenschaftliches Studium
Sie erheben die Business Requirements von Analytics- und Reporting-Anforderungen Sie entwickeln und implementieren Datenmodelle, Reports und Schnittstellen Sie betreuen die BI- und Reporting
design of patient-level data registries Lead the development of the SAP(s) for interim and final reports Contribute to the exploratory analysis and communicate results through internal/external
evaluation of results Maintenance of the lab equipment and troubleshooting Contribution to reports (or section of reports) under the supervision of the lab head Laboratory technician with profound
including statistical evaluations and preparation of relevant reports Preparation of stability protocols and reports for drug substances and drug products Plan, distribute, manage, optimize and review
members regarding actions to understand and remove roadblocks in completing changes Review and report KPIs to ensure timelines of change control actions Relevant degree in engineering Profound
Delivering the following study-related documents: Protocol and Core Informed Consent Form (CICF), Clinical Study Report (CSR) Contribute to the following documents generated by other departments
instruments/equipment Contribute to lab procedures, reports and/or instructions and/or SOP’s Contribute to evaluation of new lab equipment Actively participate in knowledge exchange Train and coach
approval of releases Record the new credit limits customers in SAP Prepare the monthly reports (Sales, A/R, expenses, etc) for Management Centers Process the Purchase Requests / Purchase Orders for 3rd
biometrician in the study-implementing teams of the clients Creating analysis plans Carrying out and / or monitoring the analyzes Cooperation in the report preparation Development of programs for the
systems, tools and reports Create and maintain centralized project/team work-spaces, including document creation and/or maintenance Assist with effective communication and information sharing via
the development of Clinical Study Report Ensure compliance of all activities in accordance with the clinical study protocol, ICH-GCP, local Regulations and Quality System documents Oversee adherence
Lead and/or contribute to the development of the clinical study database and all components in collaboration with the Study Data Manager, who provides the core specifications Development of reports