Basel, Basel, Switzerland
I am a dedicated Clinical Data Manager with extensive experience in the pharmaceutical industry, specializing in clinical trials and data management. Throughout my career, I have worked with leading pharmaceutical companies and CROs, ensuring the integrity, accuracy, and compliance of clinical data. Proficient in Veeva CDMS and other EDC systems, I excel at optimizing data workflows and collaborating with cross-functional teams to drive successful clinical studies. Passionate about innovation in clinical research, I thrive in dynamic environments and am committed to delivering high-quality data that supports the development of life-changing treatments.
-Lead Data Manager activities. Oversight of CRO and external vendors. -Subject Matter Expert of Veeva CDMS and CDB– creation of data standards library, systems validation, RIA -Data cleaning, PDs and coding review, data transfers and reconciliation overview. -Lead data review meetings with study teams to discuss data quality issues, identify trends, and implement corrective actions as needed. -Proactively identify opportunities for process improvement and efficiency gains within the data management function, research of new AI trends
-Lead Data Manager activities. Communication with external vendors. -Protocol and study-related documents creation and review. -eCRF design and set-up coordination. Management of data base lock.
-CRF Design and review, production of the DMP. -Testing of clinical study database -Review of draft protocols and CRF’s for consistency and accuracy. -Generation of project status reports -Coordinate and oversee the testing of the database structure and edit check programs. -Query generation and resolution -Review electronic data, medical coding and quality control procedures.
Oncology Phase I clinical trials: data entry on EDC, AE/SAE reporting, ISF manteinance, queries resolution, schedule and attendance of Site Monitoring Visits, Audits and Inspections preparation and attendance
-Research and analysis of pharmacovigilance data: quality check of reportable safety information related to different drugs and therapy areas meeting the client's regulatory compliance according to the guidelines for AE tracking. - Tracking of quality management system activities including CAPA -QC of SAE report - Monitoring of PV documentation.