Basel, Basel, Switzerland
Specialties: Evidence Generation activities, Medical Governance, Research Collaboration, Clinical trials coordination. Autoimmune and Inflammatory diseases, Risk Management,
Medical Governance over Evidence Generation activities, Risk Management, Quality, Compliance
Monitoring in Germany, Austria and Belgium: On-site monitoring (including site qualification, site initiation, interim monitoring and site close-out visits), in-house monitoring activities. Responsible for Ethics Committee Submission and support of regulatory submission. Participate to feasibility analyses Support of the Trial Leaders and Project Managers in different tasks Data Manager activities for various vaccines clinical trials and a phase I/II study onpatient with acute myeloblastic leukemia Therapeutics areas: Cardiovascular, Oncology and Vaccines
Data cleaning: review eCRF data and data listings focusing on clinical issues identified in the Data Validation Plan, query generation and resolution, review laboratory data to identify outliers and ensure accurate recording of adverse events, identify protocol violators. SAE Reconciliation: perform Data Event Report reconciliation between eCRF data and safety database. Coding: review the coding to ensure consistency and accuracy of selected terms Coordination: communication trends in data completion to the Trial Data Analyst, provide ongoing feedback on Data Management workflows and technologies to increase efficiency, work as a team player with Biometrics and Clinical staff. Therapeutic area: Dermatology
Ensure the completeness, correctness, accuracy and consistency of the clinical data and data structure across all projects in agreement with the ICH/GCP guidelines. Be involved in the setting up and conduction of data management activities (query and discrepancy management, review and testing of validation check specification, database testing, maintenance of Data Handling Manual, perform interim and final quality control). Work collaboratively with direct report including various Clinical Management staff (i.e.: biostatiticians, programmers, CRAs, project manager,...) to meet project deliverables, timelines and costs for clinical data acquisition, quality checking and reporting. Coordinate data management specific activities (query and discrepancy management, quality control, archiving). Involve in the biometrics process improvement Take responsibility as mentor for junior staff (training support) Therapeutic areas: Oncology and Women Health